REISETABLETTEN-

REISETABLETTEN-1A Pharma

Important notes (mandatory information)

Travel tablets - 1 A Pharma 50 mg tablets. Active ingredient: Dimenhydrinate. Areas of application: Medication for the prevention and treatment of travel sickness, dizziness, nausea and vomiting.

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


INSTRUCTIONS FOR USE: INFORMATION FOR USERS

Travel tablets - 1 A Pharma 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 notice 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 even worse after 2 weeks, contact your doctor.

What this package leaflet contains

1. WHAT IS TRAVEL TABLETS - 1 A PHARMA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TRAVEL TABLETS - 1 A PHARMA?
3. HOW TO TAKE TRAVEL TABLETS - 1 A PHARMA?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW TO STORE TRAVEL TABLETS - 1 A PHARMA?
6. CONTENTS OF THE PACK AND OTHER INFORMATION

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

Dimenhydrinate is an anti-nausea and vomiting agent from the group of H1 antihistamines. Travel tablets - 1 A Pharma is a medicine for the prevention and treatment of travel sickness, dizziness, nausea and vomiting. Note: Dimenhydrinate is not suitable for the sole treatment of nausea and vomiting following drug treatment for cancer (cytostatic therapy). If you do not feel better or even worse after 2 weeks, contact your doctor.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING TRAVEL TABLETS - 1 A PHARMA?

Travel tablets - 1 A Pharma 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 an acute asthma attack.
• in the case of narrow-angle glaucoma.
• if you have an adrenal gland tumour (phaeochromocytoma).
• if you suffer from a disorder of blood pigment production (porphyria).
• in the case of enlargement of the prostate gland (prostate hyperplasia) with residual urine.
• if you suffer from seizures (epilepsy, eclampsia).

Warnings and precautions

Please talk to your doctor or pharmacist before taking Travel tablets - 1 A Pharma.

Travel tablets - 1 A Pharma may only be taken after consulting a doctor in the case of:

• impaired liver function.
• heart rhythm disorders (e.g. heart palpitations).
• potassium or magnesium deficiency.
• slowed heart rate (bradycardia).
• certain heart conditions (congenital QT syndrome or other clinically significant heart damage, especially coronary artery disease, conduction disorders, arrhythmias).
• concomitant use of medicines that also prolong the so-called QT interval on the ECG or lead to hypokalaemia (see section "Taking Travel tablets - 1 A Pharma with other medicines").
• chronic respiratory problems and asthma.
• narrowing at the outlet of the stomach (pyloric stenosis).

Taking Travel tablets - 1 A Pharma 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. When Travel tablets - 1 A Pharma is taken together with other centrally depressant medicines (medicines that affect the psyche, sleeping pills, sedatives, painkillers and anaesthetics), the effects of both medicines may be mutually reinforced. The "anticholinergic" effect of Travel tablets - 1 A Pharma (see section 4 "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]). If Travel tablets - 1 A Pharma is taken together with so-called monoamine oxidase inhibitors (medicines that are also 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 central nervous system and respiratory function may become more impaired. Therefore, Travel tablets - 1 A Pharma must not be taken at the same time as monoamine oxidase inhibitors.

The simultaneous administration of medicines that also prolong the so-called QT interval on the ECG, e.g. medicines for heart rhythm disorders (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 which can lead to potassium deficiency (e.g. certain diuretics) should be avoided.

Taking Travel tablets - 1 A Pharma together with medicines for high blood pressure can lead to increased fatigue. The doctor should be informed about the use of Travel tablets - 1 A Pharma before carrying out allergy tests, as false-negative test results are possible. It should also be noted that Travel tablets - 1 A Pharma may mask any hearing damage that may occur during treatment with certain antibiotics (aminoglycosides).

Taking Travel tablets - 1 A Pharma with alcohol

Alcohol should not be consumed during treatment with Travel tablets - 1 A Pharma, as alcohol can alter and increase the effect of Travel tablets - 1 A Pharma 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 are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

Dimenhydrinate, the active ingredient in Travel tablets - 1 A Pharma, can trigger premature labour. The safety of using Travel tablets - 1 A Pharma during pregnancy has not been proven. A risk cannot be ruled out for dimenhydrinate based on clinical data. You should only take Travel tablets - 1 A Pharma after consulting your doctor and only if your doctor considers it absolutely necessary to take Travel tablets - 1 A Pharma.

Breastfeeding

Dimenhydrinate, the active ingredient in Travel tablets - 1 A Pharma, passes into breast milk. The safety of using Travel tablets - 1 A Pharma 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 Travel tablets - 1 A Pharma during breastfeeding or stop breastfeeding while taking Travel tablets - 1 A Pharma.

Driving and operating machinery

Drowsiness, memory impairment and reduced concentration may have a negative effect on driving ability or the ability to work with machinery. This applies particularly after insufficient sleep, at the start of treatment and when changing preparations, as well as in combination with alcohol (see section "Taking Travel tablets - 1 A Pharma with alcohol").

Travel tablets - 1 A Pharma contains lactose

Please only take Travel tablets - 1 A Pharma after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE TRAVEL TABLETS - 1 A PHARMA?

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 dosage of dimenhydrinate should be based on the patient's body weight. In smaller children, a single dose may be sufficient to relieve the symptoms. Unless otherwise prescribed by the doctor, daily doses of 5 milligrams per kilogram of body weight should not be exceeded. This means that children weighing less than 30 kg should generally not be given more than 2 tablets per day.

The recommended dose is:

• Adults and adolescents over 14 years of age 1– to 4–times daily 1–2 tablets (corresponding to 50 – 400 mg dimenhydrinate), but not more than 8 tablets/day (corresponding to 400 mg dimenhydrinate/day).
• Children from 6 to 14 years of age 1– to 3–times daily 1/2 – 1 tablet (corresponding to 25 – 150 mg dimenhydrinate), but not more than 3 tablets/day (corresponding to 150 mg dimenhydrinate/day).
• Dimenhydrinate-containing suppositories are available for children up to 6 years of age.

Method of administration

For the prophylaxis of travel sickness, the first dose is taken approx. 1/2 - 1 hour before the start of the journey. For the therapy of nausea and vomiting, the doses are distributed at regular intervals throughout the day. The tablets should be taken whole and with plenty of liquid. The tablet can be divided into equal doses.

Duration of use

Travel tablets - 1 A Pharma is intended for short-term use only, unless otherwise prescribed by your doctor. If symptoms persist, a doctor should therefore be consulted. At the latest after 2 weeks of treatment, your doctor should check whether treatment with Travel tablets - 1 A Pharma is still necessary.

Please talk to your doctor or pharmacist if you have the impression that the effect of Travel tablets - 1 A Pharma is too strong or too weak.

If you have taken more Travel tablets - 1 A Pharma than you should

Poisoning with dimenhydrinate, the active ingredient in Travel tablets - 1 A Pharma, can be life-threatening. Children are particularly at risk. In the event of an overdose or poisoning with Travel tablets - 1 A Pharma, a doctor (e.g. poison control centre) should be consulted immediately for advice. An overdose of Travel tablets - 1 A Pharma is primarily characterised by a clouding of consciousness, which can range from severe drowsiness to unconsciousness. The following signs are also observed: dilated pupils, visual disturbances, rapid heart rate, fever, hot, flushed skin and dry mucous membranes, constipation, anxiety and agitation, increased reflexes and delusions. In addition, convulsions and respiratory problems are possible, which can lead to respiratory paralysis and cardiovascular arrest at high doses. The severity of the poisoning and the necessary measures are assessed by the doctor.

If you forget to take Travel tablets - 1 A Pharma

Do not take twice the amount if you have forgotten to take the previous dose.

If you stop taking Travel tablets - 1 A Pharma

Do not interrupt or stop taking Travel tablets - 1 A Pharma without first talking to your doctor.

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

4. WHAT SIDE EFFECTS ARE POSSIBLE?

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

Important side effects or signs to watch out for and what to do if you are affected

If you are affected by any of the following side effects, stop taking Travel tablets - 1 A Pharma and see your doctor as soon as possible. Depending on individual sensitivity and the dose taken, the following side effects occur very frequently (may affect more than 1 in 10 people) - especially at the start of treatment: drowsiness, dizziness, 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, visual disturbances, increased intraocular pressure and difficulty urinating may occur frequently (may affect up to 1 in 10 people) as so-called "anticholinergic" side effects. Gastrointestinal complaints (e.g. nausea, pain in the stomach area, vomiting, constipation or diarrhoea) and mood swings have also been observed. Furthermore, there is the possibility of so-called "paradoxical reactions" such as restlessness, agitation, insomnia, anxiety or trembling, especially in children. Allergic skin reactions and photosensitivity of the skin (avoid direct sunlight!) and liver function disorders (cholestatic jaundice) have also been reported. Blood cell damage may occur in exceptional cases.

Other possible side effects

With prolonged treatment with dimenhydrinate, the development of drug dependence cannot be ruled out. For this reason, Travel tablets - 1 A Pharma should only be used for a short period of time if possible. After prolonged daily use, sleep disturbances may occur temporarily if treatment is stopped suddenly. In such cases, treatment should therefore be discontinued by gradually reducing the dose.

Reporting of side effects

If you get 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, Department 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 TO STORE TRAVEL TABLETS - 1 A PHARMA?

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". The expiry date refers to the last day of the month indicated. Storage conditions: No special storage conditions are required for this medicine. 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 - 1 A Pharma contains

The active ingredient is: Dimenhydrinate 1 tablet contains 50 mg dimenhydrinate. The other ingredients are: Calcium hydrogen phosphate dihydrate, highly dispersed silicon dioxide, lactose monohydrate, magnesium stearate (Ph.Eur.) [vegetable], cellulose powder, carboxymethyl starch sodium (type A) (Ph.Eur.).

What Travel tablets - 1 A Pharma looks like and contents of the pack

White, round tablet with a break notch. Travel tablets - 1 A Pharma is available in PVC/PVDC-aluminium blister packs of 20 tablets.

Pharmaceutical entrepreneur

1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Telephone: 089/6138825-0

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben

This leaflet was last revised in March 2018.

Source: Information from the package leaflet
Status: 01/2020
Active ingredient: Dimenhydrinate. Areas of application: Medication for the prevention and treatment of travel sickness, dizziness, nausea and vomiting.