Patient Information Rodavan^® S Grünwalder

– please read carefully –

Dear patient,
please read this leaflet very carefully. It contains important information which you should be aware of concerning the use of this medicinal product. If you have any questions, please ask your doctor or pharmacist.

Rodavan^® S Grünwalder

50 mg tablets

Active substance:

dimenhydrinate

Composition:

1 tablet contains:
Active ingredient: dimenhydrinate 50mg

Excipients:

Calcium hydrogen phosphate 2 H₂O; lactose 1 H₂O; cellulose powder, poly-(O-carboxymethyl)-, starch, sodium salt, highly-dispersed silicon dioxide, magnesium stearate.

Pharmaceutical form and contents

Available in packs of 10 and 20 tablets.

Dimenhydrinate is an H1 antihistamine for sickness and nausea.

Pharmaceutical company:

Grünwalder Gesundheitsprodukte GmbH
Ruhlandstraße 5
83646 Bad Tölz
Germany
Telefon: (08041) 806469

Producer:

Rottendorf Pharma GmbH,
D - 59320 Enningerloh
Germany

Indications

For the prevention and treatment of nausea and sickness of various causes, in particular due to travel sickness.
Note: Dimenhydrinate is not to be used for the nausea and sickness which result from treatment for cancer (cytostatic therapy).

Contraindications

When should Rodavan^® S Grünwalder not be used?
Do not take Rodavan^® S Grünwalder if you have the following:

• an allergy to dimenhydrinate, or another antihistamine substance or another ingredient of this medicine
• acute asthma attack
• (narrow angle) glaucoma
• adrenal gland tumour (pheochromocytoma)
• disorder of haemoglobin production (porphyria)
• enlarged prostate gland (prostate hyperplasia) with urine retention
• epilepsy or eclampsia

When should you see your doctor before taking Rodavan^® S Grünwalder?
If you suffer from any of the following you should only take Rodavan^® S Grünwalder under certain conditions and with special care. Please ask your doctor about these. This advice also applies if you have ever suffered from them in the past.

Rodavan^® S Grünwalder should only be taken after consulting a doctor if you have any of the following conditions:

• reduced liver function
• cardiac arrhythmias (e.g. tachycardia)
• chronic respiratory problems and asthma
• narrowing of gastric outlet (pyloric stenosis)

Special considerations for pregnant women and nursing mothers:
Rodavan^® S Grünwalder should not be used during the third trimester because of the possibility of triggering premature uterus contractions.
During the first six months of pregnancy, Rodavan^® S Grünwalder should only be used if non- medicinal measures have proved ineffective and only then after recommendation by a doctor. Dimenhydrinate passes into breast milk in small amounts. So far, no long term negative effects have been noticed in breastfed babies. If a baby shows signs that cause concern, change to bottle feeds or the mother should stop treatment with Rodavan^® S Grünwalder. In toddlers and small children, the exact dose should be strictly adhered to (possible CNS over-stimulation).

Precautions for use and warning:

What special precautions should be taken driving in traffic or whilst working with heavy machinery or under unsafe conditions?
Drowsiness, memory loss and reduced levels of concentration could have a negative effect on driving ability or ability to work with heavy machinery. This is particularly true in connection with lack of sleep, at the outset if treatment and changing medication or in combination with alcohol. (see interactions)

Interactions

Which medicines can affect the action of Rodavan^® S Grünwalder and what must be taken into account when taking other medicines simultaneously?

When taking Rodavan^® S Grünwalder at the same time as other CNS depressants (medicines which can have a psychological effect, sleeping tablets, tranquillisers, pain killers) there can be a reciprocal increase in the effect of both medicines.

The anticholinergic effect of Rodavan^® S Grünwalder (see side effects) could be intensified in an unforeseen way through the simultaneous administration of other medication with an anticholinergic effect (e.g. Atropin, Biperiden or certain medication for depression [tricyclic antidepressants]).

The simultaneous administration of Rodavan^® S Grünwalder and so-called monoaminoxidase inhibitors (medication for treating depression) could in certain circumstances result in a life- threatening paralytic ileus, urine retention or a rise in pressure inside the eyeball. In addition, a drop in blood pressure could result and a reduction in CNS and respiratory function. Therefore do not take Rodavan^® S Grünwalder at the same time as monoaminoxidase inhibitors.

The simultaneous administration of Rodavan^® S Grünwalder with medicines for high blood pressure can lead to increased drowsiness/tiredness.

Inform your doctor beforehand if you are having allergy tests while taking Rodavan^® S Grünwalder, as false negative test results are possible.

It is important to note that any possible hearing damage caused by antibiotics (aminoglycosides) could be masked if Rodavan^® S Grünwalder is taken at the same time.

Please note that the above information is also relevant if the medicine is taken for a short duration.

Status: October 2005