Consumer medicine information

Phentermine Juno ER

Phentermine

BRAND INFORMATION

Brand name

Phentermine Juno ER

Active ingredient

Phentermine

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Phentermine Juno ER.

What is in this leaflet

This leaflet answers some common questions about Phentermine Juno ER. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. If you need any more information about Phentermine Juno please ask your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risk of you taking Phentermine Juno against the benefits it can have for you.

If you have any concerns about taking this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may want to read it again.

Your medicine

The name of your medicine is Phentermine Juno. Phentermine Juno tablets contain the active ingredient, phentermine. The release mechanism of the drug in this tablet is controlled by hydrophobic and hydrophilic release modifiers. The tablet consists of a hydrophobic wax matrix which contains a hydrophilic release modifier and the drug substance.

What Phentermine Juno is used for

Phentermine Juno is used to reduce body weight in obese or overweight patients. Your doctor will assess whether Phentermine Juno is suitable for you. Phentermine Juno works by directly affecting the area of the brain that controls your appetite making you feel less hungry.

Ask your doctor if you have any questions about why this medicine has been prescribed for you.

Phentermine Juno should be used as a part of an overall weight management plan which should include a medically controlled diet and exercise program.

Phentermine Juno is available only with a doctor's prescription.

Your doctor may prescribe Phentermine Juno for another purpose. If you are not sure why you are taking this medicine ask your doctor.

Before you take Phentermine Juno

When you must not take it

Do not take Phentermine Juno if you have an allergy to:

  • any medicine containing phentermine
  • any of the ingredients listed at the end of this leaflet
  • any other similar medicines used to reduce weight

Some of the symptoms of an allergic reaction may include:

  • shortness of breath
  • wheezing or difficulty breathing
  • swelling of the face, lips, tongue, or other parts of the body
  • rash, itching or hives on the skin

Do not give this medicine to a child under the age of 12 years. Safety and effectiveness in children younger than 12 years have not been established.

Do not take this medicine if you have any of the following medical conditions:

  • very high blood pressure
  • high blood pressure in the lung
  • problems with the valves in your heart
  • disease related to blood vessels in the brain
  • severe heart disease including changes in the rhythm or rate of the heart beat
  • narrowing of the blood vessels due to thickening or hardening of the blood vessel wall
  • overactive thyroid gland
  • psychiatric illness including anorexia nervosa (loss of appetite) and depression
  • glaucoma (high pressure in the eye)

Do not use this medicine:

  • if you are currently taking, or have taken within the last 14 days, antidepressant medicines from the mono-amine oxidase inhibitor (MAOI) class such as phenelzine (eg Nardil) or tranylcypromine (eg Parnate).
  • if you have previously misused drugs or alcohol

Do not take this medicine after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering. If it has expired or is damaged, return it to your pharmacist for disposal.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you start to take it

Tell your doctor if you have allergies to any medicines, foods, preservatives or dyes.

Tell your doctor or pharmacist if you are pregnant or plan to become pregnant or are breastfeeding. Your doctor or pharmacist can discuss with you the risks and benefits involved.

Tell your doctor if you:

  • have high blood pressure
  • have heart disease such as angina (chest pain)
  • have diabetes
  • have epilepsy

If you have not told your doctor about any of the above, tell him/ her before you start taking Phentermine Juno.

Taking other medicines

Tell your doctor or pharmacist if you are taking any other medicines, including any that you get without a prescription from your pharmacy, supermarket or health food shop.

Some medicines and Phentermine Juno may interfere with each other. These include:

  • any medicines for weight reduction
  • any medicines for depression or obsessive compulsive disorder such as fluoxetine (eg Prozac, Erocap, Lovan, Zactin); sertraline (eg, Zoloft); paroxetine (eg Aropax); clomipramine (eg Anafranil, Placil)
  • ergot-like medicines for migraine such as ergotamine (eg Cafergot, Ergodryl, Migral)
  • any cough and cold remedies containing pseudoephedrine, phenylpropanolamine or phenylephrine
  • thyroid hormones
  • any medication for mental illness
  • medicines for lowering high blood pressure including clonidine, methyldopa or guanethidine.

These medicines may be affected by Phentermine Juno or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor and pharmacist have more information on medicines to be careful with or avoid while taking this medicine.

How to take Phentermine Juno

Carefully follow all directions given to you by your doctor or pharmacist and never change the dose yourself. They may differ from the information contained in this leaflet.

If you do not understand the instructions on the box, ask your doctor or pharmacist for help.

How much to take

In adults and adolescents over 12 years, the usual dose of Phentermine Juno is one tablet every day. However, your doctor will prescribe the right dose for you.

Increasing the dose may not necessarily make you lose more weight or make you lose weight faster. However you will most likely experience more side effects. Your doctor will tell you how long you are to take Phentermine Juno for.

How to take it

Swallow the tablets whole with plenty of water. Do not chew or open the tablets.

When to take it

Take Phentermine Juno first thing in the morning, at breakfast time so that it does not keep you awake at night.

Taking it at the same time each day will have the best effect. It will also help you remember when to take it.

It does not matter if you take this medicine before or after food.

Phentermine Juno is not recommended for elderly patients or for children younger than twelve years.

How long to take it

Take this medicine as long as your doctor tells you to.

If you forget to take it

If you forget to take your Phentermine Juno dose at breakfast take it no later than lunchtime. Alternatively, skip the dose you missed and take your next dose at the normal time on the next day. If you take Phentermine Juno any later than lunch-time you may have trouble sleeping at night.

Never take a double dose to make up for a dose you have missed.

If you have trouble remembering when to take your medicine, ask your pharmacist for some hints.

If you take too much Phentermine Juno

Immediately telephone your doctor or the Poisons Information Centre (Australia: telephone 13 11 26; New Zealand: 0800 POISON or 0800 764 766) for advice, or go to Accident and Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Phentermine Juno. Do this even if there are not signs of discomfort or poisoning. You may need urgent attention.

While you are using Phentermine Juno

If you are about to be started on any new medicine remind your doctor and pharmacist that you are taking Phentermine Juno.

Tell any other doctors, dentists and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.

If you become pregnant while taking this medicine, tell your doctor immediately.

If you are about to have any blood tests tell your doctor that you are taking this medicine. It may interfere with the results of some tests.

Keep all of your doctor's appointments so that your progress can be checked.

Tell your doctor immediately if you experience sudden or rapid weight loss, difficulty breathing, chest pain, fainting, and swelling of the lower limbs and if you can not exercise as much as you usually can.

Things you must not do

Do not take Phentermine Juno to treat any other complaints unless your doctor tells you to.

Do not give your medicine to anyone else, even if they have the same condition as you.

Things to be careful of

Be careful driving or operating machinery until you know how Phentermine Juno affects you.

DO NOT drink alcohol whilst taking Phentermine Juno.

Check with your doctor or pharmacist before you start to take any cough or cold medication.

Side Effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Phentermine Juno.

This medicine helps most people with a weight problem but it may have unwanted side effects in a few people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical attention if you get some of the side effects.

Do not be alarmed by the following lists of side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if you experience:

  • heart attack
  • stroke
  • angina
  • myocardial infarction

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation.

These side effects are rare.

Tell your doctor or pharmacist if you notice any of the following and they worry you:

  • feeling more awake than usual
  • trouble sleeping
  • your heart seems to beat faster and harder
  • your blood pressure may be raised slightly
  • irregular heart beats
  • chest pain
  • feeling restless
  • feelings of extreme happiness followed by depression and tiredness
  • nervousness
  • tremor (shaking)
  • headache
  • dizziness
  • nausea
  • vomiting
  • diarrhoea or constipation
  • stomach cramps

Tell your doctor as soon as possible if you notice any of the following:

  • sudden or rapid weight loss
  • difficulty breathing
  • chest pain
  • fainting
  • swelling of the lower limbs
  • or if you can not exercise as much as you usually can
  • dry mouth or an unpleasant taste in your mouth
  • difficulty passing urine
  • skin rashes
  • impotence
  • changes in sexual drive
  • swelling of the face

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

After Using Phentermine Juno

Storage

Keep your tablets in the blisterfoil in the carton until it is time to take them. If you take the tablets out of the pack they may not keep well.

Keep Phentermine Juno in a cool dry place where the temperature stays below 30°C.

Do not store Phentermine Juno or any other medicine in the bathroom or near a sink. Do not leave them on a windowsill or in the car. Heat and dampness can destroy some medicines.

Keep them where children cannot reach them. A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If your doctor tells you to stop taking this medicine or the expiry date has passed, ask your pharmacist what to do with any medicine that is left over.

Product Description

What Phentermine Juno looks like

Phentermine Juno ER 15 mg are green film coated capsule shaped tablets. (AUST R 309879)

Phentermine Juno ER 30 mg are red film coated capsule shaped tablets. (AUST R 309909)

Phentermine Juno ER 40 mg are orange film coated capsule shaped tablets. (AUST R 309914)

Ingredients

Phentermine Juno tablets contain:

  • phentermine hydrochloride
  • cetostearyl alcohol
  • stearic acid
  • maltodextrin
  • sorbitol
  • magnesium stearate

In addition:

Phentermine Juno ER 15 mg tablet contains:

  • Opadry II (green)

Phentermine Juno ER 30 mg tablet contains:

  • Opadry II (red)

Phentermine Juno ER 40 mg tablet contains:

  • Opadry II (red)

Phentermine Juno ER tablets are gluten-free.

Sponsor

Juno Pharmaceuticals Pty Ltd,
42, Kelso Street,
Cremorne,
VIC 3121

This leaflet was prepared in March 2020.

Published by MIMS September 2020

BRAND INFORMATION

Brand name

Phentermine Juno ER

Active ingredient

Phentermine

Schedule

S4

 

1 Name of Medicine

Phentermine (as hydrochloride).

2 Qualitative and Quantitative Composition

Phentermine Juno ER are oral film coated extended release tablets, containing the active ingredient phentermine HCl with three different strengths 15, 30 and 40 mg as phentermine base.
For the full list of excipients, see Section 6.1 List of Excipients.

3 Pharmaceutical Form

Phentermine Juno ER 15 mg are green film coated capsule shaped tablets.
Phentermine Juno ER 30 mg are red film coated capsule shaped tablets.
Phentermine Juno ER 40 mg are orange film coated capsule shaped tablets.
The release mechanism is controlled by hydrophobic and hydrophilic release modifiers. The tablet consists of a hydrophobic wax matrix which contains a hydrophilic release modifier and the drug substance.
When the drug product is taken, the GI tract fluids begin to dissolve the hydrophilic components. The dissolution process allows the gradual release of phentermine over time. Drug release is not dependent on pH.

4 Clinical Particulars

4.1 Therapeutic Indications

Phentermine is an anorectic agent indicated in the management of obesity as a short-term adjunct in a medically monitored comprehensive regimen of weight reduction based, for example, on exercise, diet (caloric/kilojoule restriction) and behaviour modification in obese patients with a body mass index (BMI) of 30 kg/m2 or greater. The treatment with Phentermine Juno ER can be initiated in overweight patients with a lower BMI (25 to 29.9 kg/m2), which increases the risk of morbidity from a number of disorders. Secondary organic causes of obesity should be excluded by diagnosis before prescribing this agent.

4.2 Dose and Method of Administration

Adults and adolescents over 12 years.

One tablet daily at breakfast, swallowed whole. Evening dosing should be avoided, as this agent may induce insomnia. It is recommended that treatment should be initiated under the care of physicians experienced in the treatment of obesity.
The recommended starting dose is 30 mg daily. Larger framed individuals may require 40 mg daily. The recommended maintenance dose, either continuous or intermittent is 15 to 40 mg daily depending on responsiveness. The recommended dose of phentermine should not be exceeded to increase the effect. Phentermine should not be combined with other appetite suppressants. Patients require medical review after a defined course of treatment, which should not exceed three months.

Children under 12 years.

Phentermine is not recommended for children under the age of 12 years as safety and efficacy have not been established.

Elderly.

Phentermine is not recommended for the elderly.

4.3 Contraindications

Pulmonary artery hypertension;
existing heart valve abnormalities or heart murmurs;
moderate to severe arterial hypertension;
cerebro-vascular disease;
severe cardiac disease including arrhythmias, advanced arteriosclerosis;
known hypersensitivity to sympathomimetic drugs;
hyperthyroidism;
agitated states or a history of psychiatric illnesses including anorexia nervosa and depression;
glaucoma;
history of drug/alcohol abuse or dependence;
concomitant treatment with Monoamine Oxidase (MAO) Inhibitors or within 14 days following their administration.

4.4 Special Warnings and Precautions for Use

Each Phentermine Juno ER extended release tablet contains phentermine hydrochloride. The innovator contains phentermine as an extended release ion exchange resin capsule. All clinical data in this product information are based on phentermine extended release capsule. Bioequivalence has been established between the two drug forms.

Special precautions.

Phentermine tablets are indicated only as short-term monotherapy for the management of exogenous obesity. The safety and efficacy of combination therapy with phentermine and any other drug products for weight loss have not been established. Therefore, coadministration of drug products for weight loss is not recommended.
Since the selective serotonin reuptake inhibitors (e.g. fluoxetine, sertraline, paroxetine), ergot-like drugs and clomipramine affect serotonin disposition there remains a theoretical risk that combination of these agents with phentermine may also be associated with cardiac valvular disease and is not recommended. There is no direct scientific evidence to confirm this theory.

Valvular heart disease.

Serious regurgitate cardiac valvular disease, primarily affecting the mitral, aortic and/or tricuspid valves, has been reported in otherwise healthy persons who had taken a combination of fenfluramine or dexfenfluramine with phentermine for weight loss. The aetiology of these valvulopathies has not been established and their course in individuals after the drugs are stopped is not known. There have been no reported cases to date of valvular heart disease occurring with the use of phentermine alone.

Primary pulmonary hypertension (PPH).

Cases of severe, sometime fatal primary pulmonary hypertension, have been reported in patients who have received anorectics. In a case-control epidemiological study, the duration of treatment with anorectic agents, not including phentermine, beyond three months significantly increases the risk of PPH. However, patients treated with phentermine require medical review at least every 3 months (see Section 4.2 Dose and Method of Administration). PPH has been reported in patients receiving fenfluramine/dexfenfluramine combined with phentermine. The possibility of an association between PPH and the use of phentermine alone cannot be ruled out; there have been very rare cases of PPH in patients who reportedly have taken phentermine alone. The initial symptom of PPH is usually dyspnoea. Other early symptoms include: angina pectoris, syncope, lower extremity oedema or the unexplained onset or aggravation of diminished exercise tolerance. Under these circumstances, treatment should be immediately discontinued and the patient referred to a specialist unit for investigation.

Use with caution in the following circumstances.

Phentermine should be used with caution in patients with mild hypertension. In the first days of treatment, determine that there is no loss of blood pressure control.
In patients receiving phentermine, response to insulin and oral hypoglycaemic agents may vary due to alterations in dietary regimes. This should be kept in mind if phentermine is used in diabetic patients.
Inappropriate use has been reported with similar drugs and the possibility of this occurrence should be considered with phentermine.
Cardiovascular and cerebrovascular events have rarely been reported, mainly in association with rapid weight loss. Weight loss should be gradual and controlled in obese patients undergoing treatment with phentermine. Phentermine should be used with caution in patients with established coronary artery disease. A single case of exacerbation of angina pectoris in a patient with established coronary artery disease has been reported.
Phentermine should be used with caution in patients receiving psychotropic drugs, including sedatives and agents with sympathomimetic activity.
Phentermine should be used with caution in epileptic patients.
Phentermine should be used with caution in patients receiving anti-hypertensive agents.

Use in the elderly.

Phentermine Juno is not recommended for the elderly.

Paediatric use.

Phentermine Juno is not recommended for children.

Effects on laboratory tests.

There are no reports to-date to suggest that phentermine interferes with laboratory or diagnostic tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Phentermine should be used with caution in patients receiving sympathomimetic agents.
Phentermine antagonises adrenergic neurone blocking drugs such as clonidine, methyldopa and guanethidine and may decrease their hypotensive effect.
The effects of Phentermine are potentiated by Monoamine Oxidase Inhibitors (see Section 4.3 Contraindications) and may result in a hypertensive crisis.
The concurrent use of thyroid hormones with phentermine may increase the CNS stimulation that can occur with phentermine.
Alcohol may increase CNS side effects such as dizziness, lightheadedness and confusion, and its concurrent use should be avoided with phentermine.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

In rats, administration of phentermine at a dose 10 times the maximum human dose on a mg/m2 basis abolished oestrous cycling. There is no information on the potential of phentermine to impair fertility in humans.
(Category B2)
Weight reduction using appetite suppression drugs is not recommended during pregnancy. In rats, administration of phentermine during late gestation at a dose 7 times the maximum human dose on a mg/m2 basis had no adverse effects on dams or offspring. There is no information on the teratological potential of phentermine. Because of inadequate evidence of safety in human pregnancy, phentermine should not be used in pregnant women.
 There is no data available on the safety of phentermine in lactation and as such, its use in lactating women should be avoided.

4.7 Effects on Ability to Drive and Use Machines

Phentermine Juno may impair the ability to perform activities requiring mental alertness, such as driving and operating machinery, and patients therefore should be cautioned accordingly.

4.8 Adverse Effects (Undesirable Effects)

Cardiovascular.

See Section 4.4 Special Warnings and Precautions for Use, Valvular heart disease, Primary pulmonary hypertension (PPH). The most common reported reactions are palpitations, tachycardia, elevation of blood pressure, precordial pain. Rare occurrences of cardiovascular or cerebrovascular events have been described with anorectic agents. In particular stroke, angina, myocardial infarction, cardiac failure and cardiac arrest have been reported.

Central nervous system.

Overstimulation, restlessness, nervousness, insomnia, tremor, dizziness and headache. Rarely euphoria may occur and this may be followed by fatigue and depression. Psychotic episodes and hallucinations are rare side effects.

Gastrointestinal.

Nausea, vomiting, dry mouth, abdominal cramps, unpleasant taste, diarrhoea, constipation.

Other.

Micturition disturbances, rash, impotence, changes in libido, facial oedema.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions at http://www.tga.gov.au/reporting-problems.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

Symptoms and signs.

Initially irritability, rapid respiration, agitation, euphoria, restlessness, hyperreflexia, disorientation and tremor, aggressiveness, hallucinations and panic states may occur, followed by cardiac arrhythmias, convulsions, fatigue, central nervous system depression and coma. Cardiovascular consequences include hypertension, hypotension and circulatory collapse. Gastrointestinal symptoms include nausea, vomiting, diarrhoea and abdominal cramps.

Management.

The treatment is largely symptomatic. Activated charcoal may reduce absorption of the medicine if given within one or two hours after ingestion. In patients who are not fully conscious or have impaired gag reflex, consideration should be given to administering activated charcoal via a nasogastric tube, once the airway is protected. Diazepam, preferably by mouth (cautiously by intravenous injection) can be used to control marked excitement and convulsions. Provided renal function is adequate, elimination of phentermine has been shown to be assisted by acidification of the urine. There is insufficient experience to recommend haemodialysis or peritoneal dialysis.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Phentermine is a sympathomimetic amine with significant anorectic activity in animal models. Its appetite suppressant effect is generally considered to be exerted through the hypothalamus, but it is not certain that this is the only effect related to weight loss. Phentermine has major effects on the dopaminergic and noradrenergic nervous systems. The cardiovascular effects include a pressor response and increase in heart rate and force of contraction.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

Absorption.

Absorption of phentermine is almost complete. The rate of absorption from Phentermine Juno ER is comparable to that of phentermine ion exchange resin complex formulations, which are significantly slower than that from immediate release phentermine hydrochloride salt formulations resulting in a lower and later peak blood level. Phentermine is readily absorbed from the gastro-intestinal tract.

Distribution.

Phentermine is readily absorbed from the gastro-intestinal tract.

Metabolism.

Following an oral dose of a phentermine capsule, one study demonstrated urinary excretion of unchanged drug ranging from 62.7% to 84.8% in 72 hours. The remainder is metabolised in the liver. The half-life of phentermine is about 25 hours.

Excretion.

A study has shown on oral administration, 62.7% to 84.8% of the unchanged drug is excreted via urine in 72 hours.
In one study in volunteers acidification of the urine reduced the half-life to 7 - 8 hours.

5.3 Preclinical Safety Data

Genotoxicity.

Phentermine was not mutagenic in a bacterial gene mutation assay, however, studies to assess the potential for chromosomal damage have not been performed.

Carcinogenicity.

No studies have been performed to determine the potential of phentermine for carcinogenesis.

6 Pharmaceutical Particulars

6.1 List of Excipients

Cetostearyl alcohol, stearic acid, maltodextrin, sorbitol, magnesium stearate.
In addition, Phentermine Juno ER 15 mg tablets also contain Opadry II complete film coating system 85F210076 Green; Phentermine Juno ER 30 mg tablets also contain Opadry II complete film coating system 85F250018 Red and Phentermine Juno ER 40 mg tablets also contain Opadry II complete film coating system 85F250052 Red.
Phentermine Juno ER tablets are gluten-free and gelatin free. It does not contain materials of animal origin.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Store below 30°C.

6.5 Nature and Contents of Container

Tablets supplied in polyamide/aluminium/PVC blisters.
Phentermine Juno ER tablets 15 mg are supplied in pack sizes of 30 and 90 tablets.
Phentermine Juno ER tablets 30 mg are supplied in pack sizes of 30 and 90 tablets.
Phentermine Juno ER tablets 40 mg are supplied in pack sizes of 30 and 90 tablets.

Pack size.

Pack size of 30's, and 90's#.
# Not currently distributed in Australia.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical name.

Phentermine (phenyl tertiary butylamine, C10H15N).

Chemical structure.


CAS number.

Phentermine - 122-09-8.
Phentermine hydrochloride - 1197-21-3.

7 Medicine Schedule (Poisons Standard)

Schedule 4 - Prescription only Medicine.

Summary Table of Changes