SUPERPEP

SUPERPEP Travel Chewing Gum Coated Tablets 20 mg

Important notes (mandatory information)

Superpep Travel Chewing Gum Dragees 20 mg. Active ingredient: Dimenhydrinate. Areas of application: for the prevention and treatment of nausea and vomiting in milder cases of travel sickness.

For risks and side effects, read the package leaflet and consult your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Superpep Travel Chewing Gum Dragees 20 mg, for use in children and adults
Active ingredient: Dimenhydrinate

Read the entire package leaflet carefully before you start taking this medicine, because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. See section 4.
• If you do not feel better or if you feel worse, contact your doctor.

What this package leaflet contains

1. WHAT ARE SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG?
3. HOW TO USE SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT ARE SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG AND WHAT ARE THEY USED FOR?

Superpep Travel Chewing Gum Dragees 20 mg are an anti-nausea and vomiting medication from the group of H1 antihistamines. Superpep Travel Chewing Gum Dragees 20 mg are used for the prevention and treatment of nausea and vomiting in milder cases of travel sickness.

2. WHAT SHOULD YOU CONSIDER BEFORE USING SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG?

Superpep Travel Chewing Gum Dragees 20 mg must not be used:

• if you are allergic to dimenhydrinate, other antihistamines, levomenthol or any of the other ingredients of this medicine listed in section 6,
• if you have an acute asthma attack,
• if you have glaucoma (narrow-angle glaucoma),
• if you have an adrenal gland tumor (pheochromocytoma),
• if you have a blood pigment production disorder (porphyria),
• if you have an enlarged prostate gland (prostate hyperplasia) with residual urine,
• if you have seizures (epilepsy, eclampsia),
• if you have bronchial asthma or other respiratory diseases associated with pronounced hypersensitivity of the airways,
• in infants and toddlers under 2 years of age (risk of laryngospasm).

Warnings and precautions

Please talk to your doctor or pharmacist before using Superpep Travel Chewing Gum Dragees 20 mg:

• if your liver function is impaired,
• if you have heart rhythm disorders (e.g. heart palpitations),
• if you have potassium or magnesium deficiency,
• if you have a slowed heart rate (bradycardia),
• if you have certain heart conditions (congenital QT syndrome or other clinically significant heart damage, especially coronary artery disease, conduction disorders, arrhythmias),
• if you are taking other medicines that also prolong the so-called QT interval on the ECG or lead to hypokalemia (see "When using Superpep Travel Chewing Gum Dragees 20 mg with other medicines"),
• if you have chronic respiratory problems and asthma,
• if you have a narrowing at the outlet of the stomach (pyloric stenosis).

Children

In children, the use of Superpep Travel Chewing Gum Dragees 20 mg requires their safe handling of chewing gum.

Elderly people

In denture wearers, the possible adhesion of the chewing gum of Superpep Travel Chewing Gum Dragees 20 mg to the denture must be taken into account.

Use of Superpep Travel Chewing Gum Dragees 20 mg with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken or plan to take any other medicines. When Superpep Travel Chewing Gum Dragees 20 mg is used together with other centrally depressant drugs (drugs that affect the psyche, sleeping pills, sedatives, pain relievers and anesthetics), the effects of each other can be mutually enhanced. The "anticholinergic" effect of Superpep Travel Chewing Gum Dragees 20 mg (see "What side effects are possible?") can be unpredictably increased by the simultaneous administration of other substances with anticholinergic effects (e.g. atropine, biperiden or certain antidepressants [tricyclic antidepressants]). Due to existing interactions, Superpep Travel Chewing Gum Dragees 20 mg must not be used at the same time as so-called monoamine oxidase inhibitors (medicines that are also used to treat depression). Avoid concomitant use with medicines that also prolong the so-called QT interval on the ECG, e.g. antiarrhythmics (Class IA or III), certain antibiotics (e.g. erythromycin), cisapride, antimalarials, anti-allergy or gastrointestinal ulcer medicines (antihistamines), medicines for the treatment of special mental illnesses (neuroleptics) and medicines that can lead to potassium deficiency (e.g. certain diuretics). The use of Superpep Travel Chewing Gum Dragees 20 mg together with medicines for high blood pressure can lead to increased fatigue. Inform your doctor about the use of Superpep Travel Chewing Gum Dragees 20 mg before carrying out allergy tests, as false-negative test results are possible. Please note that Superpep Travel Chewing Gum Dragees 20 mg may mask any hearing loss that may occur during treatment with certain antibiotics (aminoglycosides).

Use of Superpep Travel Chewing Gum Dragees 20 mg with alcohol

You should not drink alcohol during treatment with Superpep Travel Chewing Gum Dragees 20 mg, as alcohol can unpredictably alter and enhance the effect of Superpep Travel Chewing Gum Dragees 20 mg. Driving ability and the ability to operate machinery are also further impaired as a result.

Pregnancy and

breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Dimenhydrinate, the active ingredient in Superpep Travel Chewing Gum Dragees 20 mg, can trigger premature labor. The safety of using Superpep Travel Chewing Gum Dragees 20 mg during pregnancy has not been proven. A risk cannot be ruled out for dimenhydrinate based on clinical data. You should only take Superpep Travel Chewing Gum Dragees 20 mg after consulting your doctor and only if they consider it absolutely necessary.

Breastfeeding

Tell your doctor if you are breastfeeding. Dimenhydrinate, the active ingredient in Superpep Travel Chewing Gum Dragees 20 mg, passes into breast milk. The safety of using Superpep Travel Chewing Gum Dragees 20 mg during breastfeeding has not been proven. Since adverse effects, such as increased restlessness, on the breastfed child cannot be ruled out, you should either not take Superpep Travel Chewing Gum Dragees 20 mg during breastfeeding or stop breastfeeding while taking Superpep Travel Chewing Gum Dragees 20 mg.

Driving and operating machinery

Drowsiness, memory impairment and reduced concentration can adversely affect driving ability or the ability to work with machinery. This applies in particular after insufficient sleep, at the beginning of treatment and when changing preparations, as well as in combination with alcohol (see also "When using Superpep Travel Chewing Gum Dragees 20 mg with alcohol").

Superpep Travel Chewing Gum Dragees 20 mg contain aspartame, sorbitol, sucrose and glucose

Superpep Travel Chewing Gum Dragees 20 mg contain aspartame as a source of phenylalanine and can be harmful if you have phenylketonuria.

Superpep Travel Chewing Gum Dragees 20 mg contain sorbitol, sucrose and glucose

Therefore, please only use Superpep Travel Chewing Gum Dragees 20 mg after consulting your doctor if you are known to have an intolerance to certain sugars.

3. HOW TO USE SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG?

Always use this medicine exactly as described in this package leaflet or exactly as directed by your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults and adolescents aged 12 years and over: 3 Superpep Travel Chewing Gum Dragees 20 mg each at intervals of 1/2 hour. If necessary, more chewing gum dragees can be chewed, but no more than 7 per day. Children aged 6 to 12 years: 2 Superpep Travel Chewing Gum Dragees 20 mg each at intervals of 1/2 hour. If necessary, more chewing gum dragees can be chewed, but no more than 4 per day.

Method of administration

Superpep Travel Chewing Gum Dragees 20 mg are chewed like normal chewing gum. Start with the 1st chewing gum dragee approx. 1 hour before the start of the journey; the others follow at intervals of 1/2 hour. The chewing gum dragees should be chewed vigorously and thoroughly for 30 minutes each; the chewing gum can then be removed from the mouth. Accidental swallowing is harmless.

Duration of use

Only use Superpep Travel Chewing Gum Dragees 20 mg for a short period of time, unless your doctor has prescribed otherwise. Please see a doctor if nausea and vomiting persist despite using Superpep Travel Chewing Gum Dragees 20 mg. Please talk to your doctor or pharmacist if you have the impression that the effect of Superpep Travel Chewing Gum Dragees 20 mg is too strong or too weak.

If you have used more Superpep Travel Chewing Gum Dragees 20 mg than you should

Due to the special dosage form, an overdose of Superpep Travel Chewing Gum Dragees 20 mg is relatively unlikely. In the event of an overdose or poisoning with Superpep Travel Chewing Gum Dragees 20 mg, consult a doctor immediately for advice. An overdose of Superpep Travel Chewing Gum Dragees 20 mg is primarily characterized by a clouding of consciousness, which can range from severe drowsiness to unconsciousness. In addition, the following signs are observed: dilated pupils, blurred vision, rapid heart rate, fever, hot, flushed skin and dry mucous membranes, constipation, agitation, increased reflexes and delusions. In addition, convulsions and respiratory disorders are possible, which can lead to respiratory paralysis and cardiovascular arrest in high doses.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. WHAT SIDE EFFECTS ARE POSSIBLE?

Like all medicines, this medicine can cause side effects, although not everybody gets them.

The following categories are used as a basis for the frequency of side effects:
Very common:	more than 1 in 10 treated
Common:	1 to 10 in 100 treated
Uncommon:	1 to 10 in 1,000 treated
Rare:	1 to 10 in 10,000 treated
Very rare:	less than 1 in 10,000 treated
Not known:	frequency cannot be estimated from the available data.

Possible side effects

During the chewing of Superpep Travel Chewing Gum Dragees 20 mg, temporary numbness in the mouth area may occur. Depending on individual sensitivity and the dose taken, drowsiness and dizziness may occur, especially at the beginning of treatment. Very often there is dizziness and muscle weakness. These side effects can also lead to impairments on the following day. Dry mouth, increased heart rate (tachycardia), feeling of a blocked nose, blurred vision, increased intraocular pressure and urination disorders can often occur as so-called "anticholinergic" side effects. Gastrointestinal complaints and mood swings have also been observed. Furthermore, there is a possibility, especially in children, of so-called "paradoxical reactions" such as restlessness, agitation, insomnia, anxiety or trembling. Allergic skin reactions and photosensitivity of the skin (avoid direct sunlight!) and liver function disorders (cholestatic jaundice) have also been reported. Blood cell damage can occur in exceptional cases. The development of drug dependence is not to be ruled out with prolonged treatment with dimenhydrinate. For this reason, Superpep Travel Chewing Gum Dragees 20 mg should only be used for a short period of time if possible.

Other possible side effects

In appropriately sensitized patients, levomenthol can trigger hypersensitivity reactions (including shortness of breath). Levomenthol can cause laryngospasm in infants and children up to 2 years of age, resulting in severe respiratory distress.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This also applies to side effects not listed in this package leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. of Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SUPERPEP TRAVEL CHEWING GUM DRAGEES 20 MG?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton and blister after <EXP:>. The expiry date refers to the last day of the month indicated. Storage conditions: Store dry and do not store above 25°C.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Superpep Travel Chewing Gum Dragees 20 mg contain

The active ingredient is: Dimenhydrinate. 1 chewing gum dragee contains 20 mg dimenhydrinate. The other ingredients are: Gum base, sorbitol (Ph. Eur.), sucrose, talc, hard fat, dextrin, peppermint flavor, magnesium stearate (Ph. Eur.), bleached wax, highly dispersed silicon dioxide, levomenthol, light magnesium oxide, aspartame, methacrylic acid-methyl methacrylate copolymer (1:2) (Ph. Eur.) (MW: approx. 135000), saccharin sodium, calcium carbonate, colorant E 171, macrogol 35,000, glucose syrup, basic butyl methacrylate copolymer (Ph. Eur.) (MW: approx. 150000), povidone K 25, montanglycol wax, potassium dihydrogen phosphate. Superpep Travel Chewing Gum Dragees 20 mg are gluten-free.

What Superpep Travel Chewing Gum Dragees 20 mg look like and contents of the pack

White, round, biconvex chewing gum dragees. Superpep Travel Chewing Gum Dragees 20 mg are available in packs of 10 and 20 chewing gum dragees. In addition to Superpep Travel Chewing Gum Dragees 20 mg, Superpep Tablets 50 mg are also available.

Pharmaceutical entrepreneur and manufacturer

Hermes Arzneimittel GmbH
Georg-Kalb-Straße 5-8
82049 Großhesselohe/Munich
Tel.: 089 79102-0
Fax.: 089 79102-280

This package leaflet was last revised in July 2014.

Source: Information from the package leaflet
Status: 02/2018
Active ingredient: Dimenhydrinate. Areas of application: for the prevention and treatment of nausea and vomiting in milder cases of travel sickness.