REISETABLETTEN-

TRAVEL TABLETS-ratiopharm

Important notes (mandatory information)

Travel tablets-ratiopharm. Active ingredient: Dimenhydrinate. Areas of application: for the prevention and treatment of travel sickness, dizziness, nausea and vomiting (not during chemotherapy). Warning: Tablets contain lactose!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Travel tablets-ratiopharm 50 mg tablets
Active ingredient: Dimenhydrinate

Read the entire package leaflet carefully before you start taking this medicine, as it contains important information. Always take 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 is in this leaflet

1. WHAT IS TRAVEL TABLETS-RATIOPHARM AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TRAVEL TABLETS-RATIOPHARM?
3. HOW SHOULD TRAVEL TABLETS-RATIOPHARM BE TAKEN?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD TRAVEL TABLETS-RATIOPHARM BE STORED?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

1. WHAT IS TRAVEL TABLETS-RATIOPHARM AND WHAT IS IT USED FOR?

Travel tablets-ratiopharm is a medicine for dizziness, nausea and vomiting from the group of H1 antihistamines. Travel tablets-ratiopharm is used for the prevention and treatment of travel sickness, dizziness, nausea and vomiting (not during chemotherapy).

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TRAVEL TABLETS-RATIOPHARM?

Travel tablets-ratiopharm must not be taken:

• if you are allergic to dimenhydrinate, other antihistamines or any of the other ingredients of this medicine listed in section 6
• in premature and newborn babies
• during pregnancy
• during breastfeeding
• in the case of seizures (epilepsy, eclampsia)
• in the case of an acute asthma attack
• in the case of an enlarged prostate gland (prostate adenoma) with residual urine
• in the case of increased intraocular pressure (glaucoma) with a narrow chamber angle
• in the case of an adrenal gland tumor (pheochromocytoma)
• in the case of alcohol abuse
• in the case of impaired cerebral blood flow (cerebrovascular insufficiency)
• in the case of aminoglycoside antibiotic treatment, as the potentially ototoxic effects caused by aminoglycoside antibiotics may be masked
• in the case of a porphyria disorder
• in the case of concomitant therapy with monoamine oxidase inhibitors (certain medicines used to treat depression)

Warnings and precautions

Please talk to your doctor or pharmacist before taking Travel tablets-ratiopharm:

• in the case of impaired liver function
• in the case of cardiac arrhythmias (e.g. palpitations)
• in the case of potassium or magnesium deficiency
• in the case of a slow heart rate (bradycardia)
• in the case of certain heart conditions (congenital QT syndrome or other clinically significant heart damage, in particular coronary artery disease, conduction disorders, arrhythmias)
• in the case of concomitant use of medicines that also prolong the so-called QT interval in the ECG or lead to a potassium deficiency in the blood (hypokalaemia) (see "Taking Travel tablets-ratiopharm with other medicines")
• in the case of chronic respiratory problems and asthma
• in the case of a narrowing at the outlet of the stomach (pyloric stenosis)

Taking Travel tablets-ratiopharm with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or intend to take/use any other medicines. In the case of concomitant administration of Travel tablets-ratiopharm with so-called monoamine oxidase inhibitors (medicines used to treat depression), life-threatening intestinal paralysis, urinary retention or an increase in intraocular pressure may develop. In addition, blood pressure may drop and there may be an increased impairment of the function of the central nervous system and respiration. Therefore, Travel tablets-ratiopharm must not be taken at the same time as monoamine oxidase inhibitors (see "Travel tablets-ratiopharm must not be taken"). It should also be noted that Travel tablets-ratiopharm may mask any hearing loss that may occur during treatment with certain antibiotics (aminoglycosides) (see "Travel tablets-ratiopharm must not be taken"). Concomitant use with medicines that also prolong the so-called QT interval in the ECG, e.g. medicines for cardiac arrhythmias (antiarrhythmics class IA or III), certain antibiotics (e.g. erythromycin), cisapride, antimalarials, medicines for allergies or gastrointestinal ulcers (antihistamines) or medicines for the treatment of special mental illnesses (neuroleptics), or that can lead to a potassium deficiency (e.g. certain diuretics) should be avoided (see "Warnings and precautions"). The concomitant use of Travel tablets-ratiopharm with medicines that act on the central nervous system (e.g. psychotropic drugs, sleeping pills, painkillers) can lead to a mutual intensification of the sedative or stimulating effects. The concomitant administration of Travel tablets-ratiopharm and tricyclic antidepressants, monoamine oxidase inhibitors (medicines used to treat depression) and parasympatholytics (other substances with anticholinergic effects, e.g. atropine, biperiden) intensifies the anticholinergic side effects (see section 4. "What side effects are possible?") such as dry mouth and constipation. The concomitant administration of Travel tablets-ratiopharm and antihypertensive drugs leads to an increased antihypertensive effect. The dose must be adjusted accordingly. The doctor should be informed about the intake of Travel tablets-ratiopharm before carrying out allergy tests, as false-negative test results are possible. The inhibitory effect of procarbazine (a special medicine used to treat certain cancers) on cell growth is enhanced by the concomitant administration of Travel tablets-ratiopharm. Travel tablets-ratiopharm can reduce the effect of certain cortisone preparations (glucocorticoids) and heparin. Travel tablets-ratiopharm weaken the movement disorders (EPM syndrome) caused by certain psychotropic drugs (phenothiazines).

Taking Travel tablets-ratiopharm with food, drink and alcohol

No alcohol should be consumed during treatment with Travel tablets-ratiopharm, as alcohol can alter and intensify the effect of Travel tablets-ratiopharm in an unpredictable way. 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 intend to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Travel tablets-ratiopharm must not be taken during pregnancy, as dimenhydrinate can trigger premature labor.

Breastfeeding

Dimenhydrinate passes into breast milk and should therefore not be taken during breastfeeding.

Driving and operating machinery

Even when used as intended, Travel tablets-ratiopharm can alter reactions to such an extent that the ability to actively participate in road traffic, operate machinery or work without a secure footing is impaired. This applies to an even greater extent in connection with alcohol (see also "Taking Travel tablets-ratiopharm with food, drink and alcohol").

Travel tablets-ratiopharm contains lactose

Therefore, please only take Travel tablets-ratiopharm after consulting your doctor if you are aware that you suffer from an intolerance to certain sugars.

3. HOW SHOULD TRAVEL TABLETS-RATIOPHARM BE TAKEN?

Always take 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, unless otherwise prescribed by your doctor

For the prevention of travel sickness

Take 1 tablet 3 times a day. The first tablet should be taken 30 minutes before the start of the journey.

For the treatment of travel sickness, dizziness, nausea and vomiting

Take 1 to 2 tablets every 4 hours, but no more than 6 tablets per day.

Use in children

Children aged 6 to 12 years take up to 1 tablet every 6 to 8 hours, but no more than 3 tablets per day.

Method of administration

Take the tablets preferably before meals with plenty of liquid. The tablet can be divided into equal doses.

Duration of use

Travel tablets-ratiopharm should only be taken for a few days without consulting a doctor.

If you have taken more Travel tablets-ratiopharm than you should

In the event of an overdose, drowsiness and dizziness, anticholinergic symptoms such as dry mouth, visual disturbances and gastrointestinal disorders may occur. Massive overdose leads to convulsions, mental disorders with hallucinations, restlessness, accelerated heart rate, increased blood pressure and pronounced peripheral anticholinergic symptoms. In the event of an overdose with dimenhydrinate, the active ingredient of Travel tablets-ratiopharm, call the nearest doctor for help! Children are particularly at risk if they accidentally ingest large amounts of Travel tablets-ratiopharm. Please keep the packaging of the medicine ready so that the doctor can find out about the active ingredient taken.

If you forget to take Travel tablets-ratiopharm

Do not take double the amount if you have forgotten to take the previous dose. 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 frequency information is used to evaluate side effects:
Very common:	more than 1 in 10 treated persons
Common:	1 to 10 in 100 treated persons
Uncommon:	1 to 10 in 1,000 treated persons
Rare:	1 to 10 in 10,000 treated persons
Very rare:	less than 1 in 10,000 treated persons
Not known:	frequency cannot be estimated from the available data.

Drowsiness and drowsiness often occur. Occasionally, disorders of the central nervous system with agitation and restlessness, depressed (depressive) or elevated (euphoric) mood and disorientation with illusory or delusional misperception of the environment and psychomotor restlessness, movement disorders, dizziness and convulsions may occur. In addition, gastrointestinal disorders with constipation, dry mouth, difficulty urinating, visual disturbances, increased heart rate (tachycardia), feeling of a blocked nose, increased intraocular pressure (so-called "anticholinergic" side effects) and hypersensitivity reactions with skin rashes and itching may occasionally occur. In individual cases, blood disorders (transient agranulocytosis and leukopenia) have been observed. In addition, photosensitivity of the skin (avoid direct sunlight!) and liver dysfunction (cholestatic jaundice) have been reported. The development of drug dependence cannot be ruled out with prolonged treatment with dimenhydrinate. For this reason, Travel tablets-ratiopharm should only be used for a short period of time if possible. After prolonged daily use, sleep disorders may occur temporarily if treatment is stopped suddenly. Therefore, in such cases, treatment should be discontinued by gradually reducing the dose.

What countermeasures should be taken in the event of side effects?
Your doctor will decide on any necessary countermeasures in the event of side effects.

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 about the safety of this medicine.

5. HOW SHOULD TRAVEL TABLETS-RATIOPHARM BE STORED?

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 pack after "Use by"/"Use by". The expiry date refers to the last day of the month indicated. This medicinal product does not require any special storage conditions. Do not dispose of medicines in wastewater. Ask your pharmacist how to dispose of the medicine when you stop using it. In this way, you help to protect the environment.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Travel tablets-ratiopharm contains

The active ingredient is: Dimenhydrinate. Each tablet contains 50 mg dimenhydrinate. The other ingredients are: Calcium hydrogen phosphate, lactose, microcrystalline cellulose, sodium carboxymethyl starch (Ph.Eur.), silicon dioxide, magnesium stearate.

What Travel tablets-ratiopharm looks like and contents of the pack

White, round, curved tablet with a break notch on one side. Travel tablets-ratiopharm is available in packs of 20 tablets.

Pharmaceutical entrepreneur

ratiopharm GmbH
Graf-Arco-Str. 3
89079 Ulm

Manufacturer

Merckle GmbH
Ludwig-Merckle-Str. 3
89143 Blaubeuren

This leaflet was last revised in May 2016.

Source: Information from the package leaflet
Status: 11/2017
Active ingredient: Dimenhydrinate. Areas of application: for the prevention and treatment of travel sickness, dizziness, nausea and vomiting (not during chemotherapy). Warning: Tablets contain lactose!