SUMMARY CMI

Phentermine Sandoz^®

Consumer Medicine Information (CMI) summary

The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor or pharmacist.

1. Why am I using PHENTERMINE SANDOZ?

PHENTERMINE SANDOZ contains the active ingredient phentermine. PHENTERMINE SANDOZ is used to reduce body weight in obese or overweight patients.

For more information, see Section 1. Why am I using PHENTERMINE SANDOZ? in the full CMI.

2. What should I know before I use PHENTERMINE SANDOZ?

Do not use if you have ever had an allergic reaction to PHENTERMINE SANDOZ or any of the ingredients listed at the end of the CMI.

Talk to your doctor if you have any other medical conditions, take any other medicines, or are pregnant or plan to become pregnant or are breastfeeding.

For more information, see Section 2. What should I know before I use PHENTERMINE SANDOZ? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with PHENTERMINE SANDOZ and affect how it works.

A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.

4. How do I use PHENTERMINE SANDOZ?

• In adults and children over 12 years, the usual dose of PHENTERMINE SANDOZ is one capsule every day. However, your doctor will prescribe the right dose for you. Take it for as long as your doctor tells you to.
• Swallow the capsules whole with plenty of water. Do not chew or open the capsules.
• Take PHENTERMINE SANDOZ first thing in the morning, at breakfast time so that it does not keep you awake at night.

More instructions can be found in Section 4. How do I use PHENTERMINE SANDOZ? in the full CMI.

5. What should I know while using PHENTERMINE SANDOZ?

For more information, see Section 5. What should I know while using PHENTERMINE SANDOZ? in the full CMI.

6. Are there any side effects?

Common side effects of PHENTERMINE SANDOZ include headache, dizziness, restlessness, nervousness, trouble sleeping and tremor (shaking). Serious side effects of PHENTERMINE SANDOZ include chest pain, faster and harder heart beat, sudden or quick weight loss, difficulty breathing, swelling of the face or limbs, dry mouth or unpleasant taste in your mouth, difficulty passing urine, skin rashes. For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Phentermine Sandoz^®

Active ingredient(s): phentermine

Consumer Medicine Information (CMI)

This leaflet provides important information about using PHENTERMINE SANDOZ. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using PHENTERMINE SANDOZ.

Where to find information in this leaflet:

1. Why am I using PHENTERMINE SANDOZ?
2. What should I know before I use PHENTERMINE SANDOZ?
3. What if I am taking other medicines?
4. How do I use PHENTERMINE SANDOZ?
5. What should I know while using PHENTERMINE SANDOZ?
6. Are there any side effects?
7. Product details

1. Why am I using PHENTERMINE SANDOZ?

PHENTERMINE SANDOZ contains the active ingredient phentermine. Phentermine is combined with a resin which slowly releases the phentermine so the effect of PHENTERMINE SANDOZ lasts all day.

PHENTERMINE SANDOZ works by directly affecting the area of the brain that controls your appetite making you feel less hungry.

PHENTERMINE SANDOZ is used to reduce body weight in obese or overweight patients. Your doctor will assess whether PHENTERMINE SANDOZ is suitable for you.

PHENTERMINE SANDOZ should be used as a part of an overall weight management plan which should include a medically controlled diet and exercise program. PHENTERMINE SANDOZ is available only with a doctor's prescription.

Your doctor may prescribe PHENTERMINE SANDOZ for another purpose. If you are not sure why you are taking this medicine, ask your doctor.

2. What should I know before I use PHENTERMINE SANDOZ?

Warnings

Do not use PHENTERMINE SANDOZ if you have:

• 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)
• an allergy to phentermine, any similar medications used to reduce weight, or any of the ingredients listed at the end of this leaflet.
  Some symptoms of an allergic reaction may include shortness of breath, wheezing or difficulty in breathing; swelling of the face, lips, tongue, or any other parts of the body; rash, itching or hives on the skin.
  Always check the ingredients to make sure you can use this medicine.

Do not use PHENTERMINE SANDOZ if:

• you are currently taking, or have taken within the last 14 days, antidepressant medicines from the monoamine oxidase inhibitor (MAOI) class such as phenelzine (e.g. Nardil) or tranylcypromine (e.g. Parnate)
• you have previously misused drugs or alcohol
• the expiry date on the pack has passed
• the package shows signs of tampering

Check with your doctor if you:

• have any other medical conditions such as:
  - high blood pressure
  - heart disease such as angina (chest pain)
  - diabetes
  - epilepsy
• take any medicines for any other condition
• have allergies to any medicines, foods, preservatives or dyes.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

Your doctor or pharmacist can discuss with you the risks and benefits involved.

Use in children

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.

Use in the elderly

PHENTERMINE SANDOZ is not recommended for the elderly.

3. What if I am taking other medicines?

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

Some medicines and PHENTERMINE SANDOZ may interfere with each other. These include:

• any medicines for weight reduction
• any medicines for depression or obsessive compulsive disorder such as fluoxetine (e.g. Prozac, Erocap, Lovan, Zactin); sertraline (e.g. Zoloft); paroxetine (e.g. Aropax); clomipramine (e.g. Anafranil, Placil).
• ergot-like medicines for migraine such as ergotamine (e.g. 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 SANDOZ 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.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect PHENTERMINE SANDOZ.

4. How do I use PHENTERMINE SANDOZ?

How much to take

• In adults and children over 12 years, the usual dose of PHENTERMINE SANDOZ is one capsule 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 SANDOZ for.
• Follow the instructions provided and use PHENTERMINE SANDOZ until your doctor tells you to stop.

When to take PHENTERMINE SANDOZ

• Take PHENTERMINE SANDOZ 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.

How to take PHENTERMINE SANDOZ

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

How long to take it

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

If you forget to use PHENTERMINE SANDOZ

PHENTERMINE SANDOZ should be used regularly at the same time each day. If you miss your dose at the usual time, take your PHENTERMINE SANDOZ dose at breakfast, take it no later than lunch time.

Alternatively, skip the dose you missed and take your next dose at the normal time on the next day.

If you take PHENTERMINE SANDOZ any later than lunch time you may have trouble sleeping at night.

If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to.

Do not take a double dose to make up for the dose you missed.

If you use too much PHENTERMINE SANDOZ

If you think that you have used too much PHENTERMINE SANDOZ, you may need urgent medical attention.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using PHENTERMINE SANDOZ?

Things you should do

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

Call your doctor straight away if you:

• Are experiencing sudden/rapid weight loss, difficulty breathing, chest pain, fainting, and swelling of the lower limbs and if you cannot exercise as much as you usually can.
• Become pregnant while taking PHENTERMINE SANDOZ

Remind any doctor, dentist or pharmacist you visit that you are using PHENTERMINE SANDOZ.

Things you should not do

• Do not take PHENTERMINE SANDOZ to treat any other complaints unless our doctor tells you to.
• Do not give your medicines to anyone else, even if they have the same condition as you.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how PHENTERMINE SANDOZ affects you. PHENTERMINE SANDOZ may cause dizziness in some people.

Drinking alcohol

DO NOT drink alcohol whilst taking PHENTERMINE SANDOZ.

Looking after your medicine

Store in a cool dry place below 30°C.

Protect from light.

Heat and dampness can destroy some medicines.

Keep your capsules in the blister foil in the carton until it is time to take them.

If you take the capsules out of the pack they may not keep well.

Follow the instructions in the carton on how to take care of your medicine properly.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

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. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What PHENTERMINE SANDOZ contains

PHENTERMINE SANDOZ capsules are gluten free.

Do not take this medicine if you are allergic to any of these ingredients.

What PHENTERMINE SANDOZ looks like

PHENTERMINE SANDOZ capsules are available in three strengths in packs of 30 capsules:

15 mg – (AUST R 379012)

Grey and green capsule, marked with “15” in black ink.

30 mg – (AUST R 379011)

Grey and reddish-brown capsule, marked with “30” in black ink.

40 mg – (AUST R 379013)

Grey and orange capsule, marked with “40” in black ink.

Who distributes PHENTERMINE SANDOZ

Aspen Pharmacare Australia Pty Ltd
34-36 Chandos St
St Leonards NSW 2065
Australia

This leaflet was prepared in April 2025.

Published by MIMS June 2025

1 Name of Medicine

Phentermine hydrochloride.

2 Qualitative and Quantitative Composition

Each Phentermine Sandoz modified release capsule contains phentermine hydrochloride as an ion-exchange resin complex equivalent to 15, 30 or 40 mg phentermine depending on strength.

Excipient with known effect.

3 Pharmaceutical Form

Phentermine Sandoz phentermine capsules are modified release capsules and are supplied in 3 strengths as described below:
Phentermine Sandoz 15 mg are HGC size 3 gelatine capsule with opaque emerald and grey body and cap, both inscribed 15 in black ink. Containing a mixture of white powder and brilliant brown spherical beads.
Phentermine Sandoz 30 mg are HGC size 3 gelatine capsule with opaque red and grey body and cap, both inscribed 30 in black ink. Containing a mixture of white powder and brilliant brown spherical beads.
Phentermine Sandoz 40 mg are HGC size 3 gelatine capsule with opaque orange and grey body and cap, both inscribed 40 in black ink. Containing a mixture of white powder and brilliant brown spherical beads.
The ion-exchange resin is quite stable, highly insoluble and without pharmacological effect until it reacts with cations (hydrogen, potassium, sodium etc.) present in the gastrointestinal fluids. Phentermine is then released from the resin complex at a rate dependent on the total concentration of these cations. Since this concentration is fairly constant throughout the entire gastrointestinal tract, continuous and controlled ionic release occurs over a 10 to 14 hour period.

4 Clinical Particulars

4.1 Therapeutic Indications

Phentermine Sandoz 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 Sandoz 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.

Children under 12 years.

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.
Gaucoma.
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

Phentermine Sandoz capsules 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, co-administration 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.

Primary pulmonary hypertension (PPH).

Use with caution in the following circumstances.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

Phentermine Sandoz should be used with caution in patients receiving sympathomimetic agents. Phentermine Sandoz antagonises adrenergic neurone blocking drugs such as clonidine, methyldopa and guanethidine and may decrease their hypotensive effect. The effects of Phentermine Sandoz 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 Sandoz may increase the CNS stimulation that can occur with Phentermine Sandoz. Alcohol may increase CNS side effects such as dizziness, light-headedness and confusion, and its concurrent use should be avoided with Phentermine Sandoz.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

Phentermine Sandoz 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.

Central nervous system.

Gastrointestinal.

Other.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131126 (Australia).

Symptoms.

Treatment.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

Absorption.

Metabolism and excretion.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Each Phentermine Sandoz capsule also contains sodium polystyrene sulfonate, lactose monohydrate, liquid paraffin, magnesium stearate, Empty Hard Gelatin Capsule Size 3 Emerald 94W/ Grey 70W (ARTG PI No: 111876 - 15 mg strength), Empty Hard Gelatin Capsule Size 3 Red 11N/ Grey 70W (ARTG PI No: 111878 - 30 mg strength), Empty Hard Gelatin Capsule Size 3 Orange 25C/ Grey 70W (ARTG PI No: 111877 - 40 mg strength) and Opacode monogramming ink S-1-17823 Black (ARTG PI No: 12108).

Excipient with known effect.

6.2 Incompatibilities

Phentermine Sandoz should be used with caution in patients receiving sympathomimetic agents. Phentermine Sandoz antagonises adrenergic neurone blocking drugs such as clonidine, methyldopa and guanethidine and may decrease their hypotensive effect. The effects of Phentermine Sandoz 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 Sandoz may increase the CNS stimulation that can occur with Phentermine Sandoz. Alcohol may increase CNS side effects such as dizziness, lightheadedness and confusion, and its concurrent use should be avoided with Phentermine Sandoz.

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. Protect from light.

6.5 Nature and Contents of Container

Phentermine Sandoz phentermine capsules are supplied in aluminium/aluminium blister strips.
Pack size - 30 capsules.

6.6 Special Precautions for Disposal

No special instructions are necessary.

6.7 Physicochemical Properties

Chemical structure.

CAS number.

7 Medicine Schedule (Poisons Standard)

Prescription only medicine (S4).

Summary Table of Changes