Consumer medicine information

Remotiv

Hypericum perforatum flowering herb top dry

BRAND INFORMATION

Brand name

Remotiv

Active ingredient

Hypericum perforatum flowering herb top dry

Schedule

Unscheduled

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Remotiv.

WHAT IS IN THIS LEAFLET

This leaflet answers some common questions about Remotiv. It does not contain all the available information. It does not take the place of talking to your health professional.

If you have any questions about taking this medicine, ask your health professional.

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

WHAT REMOTIV IS USED FOR

Remotiv supports healthy mood balance and helps relieve the symptoms of stress.

About Remotiv

Remotiv is a clinically researched natural medicine used to:

  • support healthy mood and emotional balance
  • help relieve stress, mild anxiety and nervous tension.

Remotiv works indirectly on chemicals in the brain such as serotonin, dopamine and noradrenaline that are linked with stress, tension and anxiety.

Remotiv contains a specific extract of St John's wort referred to as Ze 117. This exclusive formula is produced with patented methods that help to ensure the consistency of its composition and product quality. Remotiv has been used worldwide for 20 years.

This medicine is well tolerated and non-habit forming.

Ask your health professional if you have any questions about why this medicine has been recommended for you. Your health professional may have recommended it for another reason.

BEFORE YOU TAKE REMOTIV

When you must not take it

Do not take Remotiv if you have an allergy to:

  • any medicine containing St John's wort extract, or any of the excipients,
  • any of the ingredients listed at the end of this leaflet.

Do not take this medicine if you are hypersensitive to light.

Do not take this medicine if you are taking medicines for depression.

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 you are not sure whether you should start taking this medicine, talk to your health professional.

Before you start to take it

St John's wort affects the way many prescription medications work, including the oral contraceptive pill. Consult your health professional.

Tell your health professional if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your health professional if you have or have had any of the following medical conditions:

  • Depression
  • Light hypersensitivity
  • Impaired liver or kidney function

Tell your health professional if you have lactose intolerance. Remotiv tablets contain a small amount of lactose (120 mg) in each tablet.

Tell your health professional if you are going to have surgery. Remotiv should be stopped at least 5 days before surgery and restarted when your health professional tells you.

Pregnancy and Breastfeeding

Do not take Remotiv if you are planning a pregnancy, are pregnant or breastfeeding. Your health professional can discuss with you the risks and benefits involved in taking Remotiv during these life stages.

Children

Do not give this medicine to a child under the age of 18 years. Safety and effectiveness in children younger than 18 years have not been established.

Taking other medicines

Tell your health professional if you are taking any other medicines, including any that you get without a prescription.

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

  • Certain antidepressants and other serotonergic substances
  • Certain immunosuppressants (medicines used to suppress the immune response)
  • Certain anti-retroviral substances (medicines used in HIV)
  • Cytostatics (medicines used in cancer)
  • Certain oral anticoagulants (medicines used to prevent blood clots)
  • Hormonal contraceptives
  • Steroid hormones (if taken or given intravenously)
  • Benzodiazepines (medicines used for sleep aid or sedatives)
  • Certain anticonvulsants
  • Digoxin (medicine for cardiac insufficiency)
  • Certain statins (medicines used for elevated blood lipids)
  • Methadone
  • Theophylline (medicine used for respiratory diseases)
  • Verapamil (medicine used for hypertension and/ or angina)

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

See your health professional if you are taking or plan to take any of the above medications before taking Remotiv.

HOW TO TAKE REMOTIV

Always take Remotiv as directed in this leaflet, or as recommended by a health professional. You should always check with your health professional if you are not sure. If symptoms persist consult your health professional.

How much to take

Take 1 tablet morning and evening or as directed by your health professional.

How to take it

Swallow the tablets whole with water.

When to take it

Take one tablet in the morning and one in the evening with or after a meal.

Take your medicine at about the same time each day. Taking it at the same time each day will help you remember when to take it.

How long to take it

Relief of symptoms can be expected within 4 weeks. Remotiv offers symptomatic relief and should be continued as needed. You should review this with your health professional at least every 6 weeks.

If you forget to take it

If it is less than 8 hours before your next dose, skip the dose you missed and take your next dose when you are meant to.

Otherwise, take it as soon as you remember, and then go back to taking your medicine as you would normally.

Do not take a double dose to make up for the dose that you missed. This may increase the chance of you getting an unwanted side effect.

If you are not sure what to do, ask your health professional.

If you have trouble remembering to take your medicine, ask your health professional for some hints.

If you take too much (overdose)

It is not necessary to take more Remotiv than the amount directed in the instructions of use, or by your health professional.

Telephone your health professional or the Poisons Information Centre (telephone 13 11 26) for advice, or go to Emergency at the nearest hospital, if you think that you or anyone else may have taken too much Remotiv, even if there are no signs of discomfort or overdose. You may need urgent medical attention. Skin and eye exposure to sun or other UV irradiation should be avoided for 1-2 weeks.

WHILE YOU ARE TAKING REMOTIV

Things you must do

If you are about to be started on any new medicine, remind your health professional that you are taking Remotiv.

Tell any other health professionals who treat you that you are taking this medicine, including your surgeon and anaesthetist if you are planning surgery.

If you become pregnant while taking this medicine, stop taking Remotiv and tell your health professional immediately.

Intense UV exposure should be avoided whilst taking Remotiv. Protect your skin and eyes from sun exposure especially if you are fair skinned.

This medicine may cause photosensitivity of the skin and eyes.

Do not take Remotiv to treat any other complaints unless your health professional tells you to.

Things to be careful of

Be careful driving or operating machinery until you know how Remotiv affects you. This medicine may cause dizziness or tiredness in some people. If you have any of these symptoms do not drive, operate machinery or do anything else that could be dangerous.

Things that would be helpful

Some self help measures may help your condition. Your health professional can give you more information about these measures.

To find out more about how to effectively manage your stress and mild anxiety visit flordis.com.au.

SIDE EFFECTS

Tell your health professional as soon as possible if you do not feel well while you are taking Remotiv.

All medicines can have side effects. Sometimes they are serious, most of the time they are not.

Remotiv may have unwanted side effects in a few people. 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 health professional to answer anyquestions you may have.

Tell your health professional if you notice any of the following and they worry you: headache, perspiration, unusual weakness, dizziness, tiredness, agitation, gastrointestinal complaints, restlessness, photosensilivity of the skin.

The above list includes the typical side effects of your medicine. They are usually mild and short-lived.

Tell your health professional as soon as possible and stop taking Remotiv if you notice any of the following: redness of the skin (like sunburn), allergic reaction of the skin.

The above list includes serious side effects that may require medical attention. These serious side effects are rare.

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

AFTER USING REMOTIV

Storage

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

Keep your tablets in a cool dry place where the temperature stays below 25°C. Keep the tablets protected from sunlight.

Keep Remotiv where children cannot reach it.

PRODUCT DESCRIPTION

What it looks like

Remotiv tablets are pink biconvex film coated tablets.

Ingredients

Each tablet of Remotiv contains:

  • Hypericum perforatum extract (Ze 117) 250 mg equivalent to dry herb top (harvested during flowering period) 1.375 g

Remotiv contains a small amount of lactose (120 mg per tablet).

Remotiv contains no added gluten, wheat, yeast, soy, sucrose, artificial colours or flavourings, tartrazine or any other azo dyes.

Supplier

Remotiv is a registered trademark of Max Zeller Sbhne AG. Remotiv is made in Switzerland by Zeller Sbhne AG and supplied in Australia by:

SFI Australasia
Level 2, 170 Pacific Highway,
St. Leonards, NSW, 2065 Australia
Telephone: 1800 334 224
Fax: 02 9431 7272
flordis.com.au

®=Registered Trademark

© Copyright

This leaflet was prepared in April 2020.

For further information on Fiordis products, please consult your health professional or visit flordis.com.au

The Flordis brand is dedicated to providing a distinctive clinically researched range of natural health products to assist better health outcomes. Flordis follows a series of strict quality control practices to help deliver a consistent medicine from one batch to the next. It's this specific medicine that is tested in clinical trials and used by millions of people worldwide.

Flordis is part of the SFI family of brands and endorsed with the SFI mark representing an unwavering commitment to quality, driven by our passion for applying science to nature.

Published by MIMS July 2022

BRAND INFORMATION

Brand name

Remotiv

Active ingredient

Hypericum perforatum flowering herb top dry

Schedule

Unscheduled

 

Name of the medicine

St. John's wort dry extract Ze 117.

Excipients.

Microcrystalline cellulose, macrogol 6000, magnesium stearate. Coating excipients include hypromellose, titanium dioxide, iron oxide red, macrogol 400 and 20000, and propylene glycol. Each tablet contains lactose.

Description

Each tablet contains 250 mg dry extract of St. John's wort from the aerial plant parts, Ze 117, equivalent to 1.375 g Hypericum perforatum herb.

Clinical Trials

The efficacy of Remotiv for the treatment of mood swing or reduction of anxiety and stress was demonstrated in 4 pivotal randomised controlled double blind clinical studies including 2 placebo controlled studies and 2 reference drug controlled studies. In a six week placebo controlled parallel study involving 162 patients, the use of Remotiv tablet (2 x 250 mg) was found to be significantly superior to placebo by using the clinical endpoint parameters that included mood, anxiety and sleep disturbance. The results from another placebo controlled randomised double blind study on 112 patients with symptoms of psychoaffective disorder, showed that the von Zerssan self rating mood scale score did improve in the active group compared with the placebo group.
In another six week randomized double blind clinical trial involving 324 patients, Remotiv was tested in comparison with imipramine, which is a tricyclic antidepression drug of the dibenzazepine group. The study results demonstrated the use of Remotiv (2 x 250 mg daily) was equivalent to the reference drug treatment (on a daily dose of 150 mg imipramine) with regards to the mood swing, relief of anxiety and nervous tension. In another similar six week randomised double blind trial involving 240 patients, Remotiv was tested against the reference drug fluoxetine, an antidepression drug in the selective serotonin reuptake inhibitor (SSRI) class. The therapeutic efficacy of Remotiv treatment (2 x 250 mg daily) was demonstrated to be statistically equivalent to the use of fluoxetine (20 mg daily) to relieve the nervous tension, lift up interest and health mood, and reduce stressfulness under a randomised, double blind parallel group study protocol.

Indications

Help reduce effects of mild anxiety and nervous tension.
Beneficial during times of stress.
For the relief of irritability.
Helps relieve nervous tension, stress and mild anxiety.
1. Helps reduce the effect of mild anxiety and nervous tension.
2. Helps relieve feelings of irritability.
3. Helps relieve nervous tension, stress and mild anxiety.
4. Can be beneficial during times of stress.
5. Supports healthy mood.
6. Supports emotional balance.
7. Helps maintain healthy mood and relieve mild anxiety/ nervous tension or unrest/ irritability/ restlessness by inhibiting presynaptic neuronal uptake of neurotransmitters serotonin, dopamine and noradrenalin.
8. Boosting neurotransmitters in synaptic cleft through inhibition of reuptake of neurotransmitters serotonin, dopamine and noradrenalin.
9. St John's wort has been used in traditional western herbal medicine used as a sedative for conditions such as excitability/ nervous tension/ unrest.
10. St John's wort has been used in traditional western herbal medicine for maintenance of healthy mood and for the relief of nervous tension/ unrest.
11. Traditionally used in traditional western herbal medicine as nervine tonic and trophorestorative (meaning restoring structure and function of nervous system).
12. Traditionally used in traditional western herbal medicine to rejuvenate during times of nervous exhaustion and fatigue.
13. Can have a relaxing effect to calm excitability, restlessness, irritability, anxiety and nervous tension or unrest.

Contraindications

Remotiv must not be taken in cases of the following.
Known sensitivity to the components of St. John's wort, or one of the ingredients of Remotiv.
Known light hypersensitivity.
Patients under 18 years of age, since there is no data available for this patient group.
Remotiv must not be taken concomitantly with the following medicinal products (see Interactions with Other Medicines).
Certain immunosuppressants (e.g. cyclosporine, tacrolimus or sirolimus).
Antiretroviral HIV drugs from the group of non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and proteinase inhibitors (e.g. indinavir).
Certain cytostatics (e.g. imatinib and irinotecan).
Oral anticoagulants of the coumarin type.
Digoxin.
Hormonal contraceptives.
Methadone.
Antidepressives.
Others, for example anticonvulsants, lipid lowering substance, theophylline, steroidal hormones.
Remotiv 250 mg tablet contains lactose and patients with lactose intolerance should consult their medical professional prior to use.

Precautions

Remotiv should not be taken by patients with depression.
St. John's wort extracts should only be taken with certain other drugs after critical evaluation due to the known interactions with several substance groups (see Interactions with Other Medicines). If other drugs must be taken concomitantly, caution is indicated at the beginning and the end of therapy as well as for dosage modification.
Due to the risk of severe interactions with drugs applied before or during surgery, Remotiv should be discontinued at least 5 days before surgery and restarted after medical consultation.
Very rarely and especially in fair skinned persons, skin reactions, such as sunburn-like skin reddening, may occur after the ingestion of St. John's wort preparations and subsequent sunlight exposure. If such symptoms occur the treatment must be discontinued. During intake of Remotiv, skin and eyes should be protected from strong sun exposure.

Use in particular groups.

Elderly.

No change in dosage.

Children.

Use of St. John's wort extract is not recommended for children under 18 years old.

Liver and kidney impairment.

No clinical trial data in patients with impaired liver or kidney function is available. Therefore in these patients Remotiv should be taken under medical supervision.

Use in pregnancy.

There is no clinical data available on the treatment during pregnancy and the potential risk for St. John's wort extracts is not known. It is not known whether the ingredients of Remotiv pass into breast milk. It is recommended that a healthcare practitioner should be consulted for the use of Remotiv during pregnancy and lactation.

Use in lactation.

See Use in pregnancy.

Effect on the ability to drive and operate machinery.

In a study with 19 healthy volunteers no influence of Remotiv on the fitness to drive and to operate machines was observed. The ability to react, the fitness to drive and operate machines could, however, be impaired in general due to the symptoms for which the treatment is intended, as well as in connection with the described side effects. Medical advice should be sought.

Interactions

Phramacokinetic interactions.

Data available on interactions indicate an induction of the cytochrome P450 system by St. John's wort extracts (especially CYP3A4) on one hand, and on the other an induction of transport proteins (P-glycoprotein, e.g. with digoxin). This can lead to a reduction in plasma concentrations, and to a weakening of the therapeutic effect of several comedicated drugs, as well as potentially severe consequences, especially for substances with a narrow therapeutic range.
Plasma levels and/or the effect of interactive drugs, especially those with a narrow therapeutic range, should therefore be monitored closely at the beginning and end of therapy, as well as in cases of dosage changes of the St. John's wort preparation.
In reverse, a sudden discontinuation of St. John's wort preparations can lead to an increase in plasma concentrations of comedicated drugs with possibly toxic effects.
In case of an accidental intake of St. John's wort preparations together with interactively acting substances, the St. John's wort preparation should, generally, be discontinued step by step. Such interactions pertain especially to the following pharmaceuticals or drug classes.

Absolute contraindications.

Immunosuppressants (cyclosporine, tacrolimus, sirolimus).

Patients with a suppressed immune system from cyclosporine, tacrolimus or sirolimus must not be treated with St. John's wort at the same time. St. John's wort leads to a rapid and marked decrease in plasma levels and loss of the immunosuppressive effect with potentially severe consequences (transplant rejection).

Antiretroviral substances from the group of non-nucleoside reverse transcriptase inhibitors and proteinase inhibitors.

When treated with non-nucleoside reverse transcriptase inhibitors (e.g. nevirapine) and proteinase inhibitors (e.g. indinavir), the intake of St. John's wort preparations is contraindicated. A study with volunteers resulted in a significant decrease in indinavir concentration after a 2 week long intake of a standardised St. John's wort preparation. It is possible that St. John's wort extracts also lead to a decrease in plasma levels and have an inhibitory effect on the efficacy of other protease inhibitors (whose metabolism primarily depend on CYP3A4).

Cytostatics (imatinib, irinotecan).

Imatinib.

During the treatment with imatinib the intake of St. John's wort preparations is contraindicated. In a drug interaction study with volunteers the concomitant intake of St. John's wort for 2 weeks led to a decrease of the AUC of imatinib by 32%, of the half-life from 12.8 to 9.0 hours, a decrease of Cmax by 18% and an increase in the clearance of imatinib by 43%. These changes were statistically significant and were confirmed in another study.

Irinotecan.

During the treatment with irinotecan the intake of St. John's wort preparations is contraindicated. In an open randomised crossover study 5 cancer patients were treated with irinotecan alone or with irinotecan and St. John's wort for 18 days. During the treatment with irinotecan and St. John's wort the AUC of the active irinotecan metabolite SN-38 was decreased by 42% compared to the group who received only irinotecan.
Interactions with other cytostatics, in whose metabolism CYP enzymes and P-glycoproteins play a role are possible.

Anticoagulants of the coumarin type (e.g. acenocoumarol, phenprocoumon, warfarin).

In patients taking oral anticoagulants, the plasma levels of these substances should be closely monitored.

Relative contraindications.

Digoxin.

The concomitant intake with digoxin led to a significant decrease in digoxin levels of about 20-25%. Therefore a concomitant intake of St. John's wort preparations with digoxin is not recommended.
In a randomized, double blind study, the inductive impact of St. John's wort extract Ze117 on the PGP transporter was investigated in healthy subjects. The pharmacokinetic parameters of digoxin were investigated in 7 subjects treated using Ze117 and in 10 subjects treated with placebo: the respective AUC of digoxin in the placebo and active groups shown no significant differences (p = 0.146).

Hormonal contraceptives.

St. John's wort can lead to reduced efficacy of hormonal contraceptives (e.g. oral products, injected depot preparations, subcutaneous implants, transdermal, intrauterine, and vaginally applied products with hormone release). Several cases of interim bleeding with so called low dose micro pills (ethinylestradiol content 30 microgram or lower) were reported internationally. Even individual cases of undesired pregnancies with hormonal contraceptives and concomitant intake of St. John's wort were reported.
A noncontrolled clinical interaction study with St. John's wort extract Ze117 and an oral hormonal contraceptive (0.02 mg ethinylestradiol and 0.15 mg 3-ketodesogestrel) in 16 healthy female subjects shown no negative influence on the pharmacokinetics of the active ingredients. The 3 P450 isoenzymes CYP2D6, CYP2C19 and CYP3A4, which are involved in the metabolism of both active ingredients were influenced by a concomitant intake of Ze117 on a nonsignificant scale. Breakthrough bleeding was not observed.
However, another clinical trial with a St. John's wort extract rich in hyperforin shown an influence on the pharmacokinetics of 3-ketodesogestrel and an explicit increase in breakthrough haemorrhaging but no ovulation.

Methadone.

St. John's wort preparations can lead to a marked efficacy reduction and a decrease in methadone concentrations. In 4 volunteers with methadone maintenance treatment the mean dose/ plasma concentration ratio was lowered on average by 47%.

Anticonvulsants.

Carbamazepine seems not to interact with St. John's wort extracts. No data are available concerning interactions with other anticonvulsants. Due to their metabolism, the following anticonvulsants should only be given cautiously with Remotiv: phenytoin, mephenytoin.

Theophylline.

Theophylline is metabolised via CYP1A2. Possible induction of CYP1A2 by Remotiv has not been investigated. Studies with other St. John's wort extracts do not show a clinically significant effect on the metabolism of theophylline.

Others.

It cannot be excluded that St. John's wort preparations also influence the metabolisms of other substances, such as certain lipid lowering substances (HMG-CoA reductase inhibitors, such as simvastatin, however not pravastatin), midazolam and orally or intravenously applied steroid hormones. St. John's wort should therefore only be given with caution together with these medicinal products.

Pharmacodynamic interactions (relative contraindications).

Antidepressives and other serotonergic substances (such as buspirone, amitriptyline, nortripityline, citalopram, escitalopram, fluoxetine, paroxetine, sertraline, and others).

St. John's wort preparations should only be taken with caution and under regular supervision together with serotonin uptake inhibitors or other serotonergic drugs. Very rarely undesired effects (serotonin syndrome) with autonomic dysfunctions (such as perspiration, tachycardia, diarrhoea, fever), mental (such as agitation, disorientation), and motor alterations (such as tremor, myoclonias) can occur in combination with serotonin uptake inhibitors or other serotonergic active substances.

Adverse Effects

Gastrointestinal disorders.

Frequent (4-6%): gastrointestinal complaints.

Nervous system.

Frequent (1-2%): headache, perspiration, asthenia.
Occasional (< 1%): dizziness, fatigue, agitation.

Skin and eyes.

Occasional: allergic reactions of the skin.
Rare: phototoxic reactions of the skin.
In cases of undesirable reactions of either skin or eyes, medication with Remotiv should be discontinued and the symptoms should be examined by healthcare practitioner.

Dosage and Administration

2 tablets daily, swallowed whole with water (in the morning and in the evening) preferably with or after a meal.
Since the effect of St. John's wort extracts builds up slowly, Remotiv should be taken over a time period of at least 14 days. A minimum length of therapy of 4-6 weeks is recommended. A longer treatment duration should only take place under medical supervision.

Overdosage

So far only one case of toxic overdose is known to have been accompanied by convulsions. It is assumed that the above described side effects would be intensified in cases of considerable overdose. Additionally an increased light sensitivity must be considered. In this case skin and eye exposure to sun or other UV irradiation (as found in solariums) should be avoided for about 1-2 weeks.
For information on the management of overdose, contact the Poisons Information Centre on 131 126 (Australia).

Presentation

Tablets (pink, biconvex, film coated), 250 mg: 60's (blister pack, AUST L 219716).

Storage

Store in a cool place below 25°C.