Drug dosage form and contents

OP with 30 or 20 retard capsules

Composition of the drug

1 retard capsule anti-adiposity RIEMSER contains:

- pharmaceutically active substances:

DL-Norephedrine hydrochloride (Phenylpropanolamine hydrochloride) 49.6 mg, thiamine chloride-hydrochloride (Vitamin B 1 ) 2.0 mg, pyridoxine hydrochloride (Vitamin B 6 ) 2.0 mg, ascorbic acid (Vitamin C) 75.0 mg

- other substances:

Saccharose, gelatine, glycerol, corn starch, shellack, talcum, carnauba wax, stearin acid, macrogol 6000, Poly (1-vinyl-2-pyrrolidine), water, E 171, E 104, E 123, E 127.

Fields of application

For the short-term, up to four-week, supportive treatment of diet-related obesity.

Antiadipositum RIEMSER is a slimming drug, anorexic drug.

RIEMSER Arzneimittel AG

An der Wiek 7

17493 Greifswald - Insel Riems

Cautionary measures for application and warning notices

Which cautionary measures must be observed?

Antiadipositum RIEMSER contains a centrally exciting substance, which only unfolds its anorexic effect for a limited time. If administered for a period longer than four weeks severe health problems may be experienced (concentration disorders, low performance, over-excitement, short temper, change of personality, insomnia and exhaustion). Therefore a pause of at lease two (better three) months should be made after a four-week treatment.

If administered without a break there is a danger of addiction and critical mental changes (misjudgements, psychoses) and depressions when stopping the administration.

What must you observe in road traffic and when working with machines and working without a safe hold?

This drug, even when administered correctly, can cause such reaction disorders that active participation in road traffic or at operating machines is impaired. This applies particularly as interaction with alcohol.

Contra-indications

When must you refrain from taking Antiadipositum RIEMSER?

Antiadipositum RIEMSER may not be taken in cases of high blood pressure, tachycardia, palpitation, cardiac and vascular diseases, diabetes, kidney disorders, thyroid disorders, psychiatric disorders, enlargement of the prostate with residual urine, glaucoma, adrenal medulla (disease with increased blood pressure), during pregnancy and when breast feeding.

When may you take Antiadipositum RIEMSER only after consulting your physician?

Persons of under 18 and of over 60 years and in cases of pathological eating disorders may only take the medicine upon recommendation of the physician.

What do you have to consider in pregnancy and when breast-feeding ?

As sufficient experience has not been made so far in the human concerning the administration of anti-adiposity RIEMSER in pregnancy and when breast feeding and furthermore, as appetite inhibitors are not to be taken in pregnancy and when breast feeding for principles of drug safety Antiadipositum RIEMSER may not be administered in these periods. Animal experiments did not point to any damaging effects with a therapeutic dose.

Dosage instructions, type and duration of administration

The following doses apply, provided your physician has not prescribed Antiadipositum RIEMSER otherwise:

If not otherwise prescribed, adults take 1 x daily 1 retard capsule Antiadipositum RIEMSER after breakfast, unchewed with a little liquid.

Note : Exceeding the dose does not result in an increased effect.

Do not take for over four weeks (refer to Warning notice under "Side effects").

Should a further reduction in weight be indicated, anti-adiposity RIEMSER may be administered again after a pause in treatment. In the meantime the intake of calories must be observed in order not to endanger the success already achieved.

Administration mistakes and overdoses

If inadvertent or intended over-doses of Antiadipositum RIEMSER are administered, the result may be a feeling of nausea or vomiting, unrest, headaches, giddiness with a considerably increased high blood pressure. Cardiac dysrhythmia, anxiety or excitation may be experienced. A physician should always be consulted in cases of overdoses, particularly when one of the above symptoms occurs.

Interactions with other drugs

Which other drugs / substances influence the effect of Antiadipositum RIEMSER?

Antiadipositum RIEMSER is not to be taken together with drugs that contain the pharmaceutical substance guanethidine (increases the sympathomimetic effect). The same applies to drugs to treat colds and asthma, which contain DL-Norephedrine (Phenylpropanolamine) or other ephedrine-type substances and drugs to increase blood pressure. Interactions with the anaesthetic Halothane (cardiac dysrhythmia) have to be considered.

The administration of Antiadipositum RIEMSER during and up to a fortnight after a treatment with monoamine oxidase (MAO) inhibitors must be refrained from as a critical increase in blood pressure may be the result. Should you be undergoing treatment with antidepressants, ask your physician or chemist before your first application of Antiadipositum RIEMSER.

Side effects

What side effects can occur when administering Antiadipositum RIEMSER?

Occasionally an increase of blood pressure, of pulse rate, cardiac dysrhythmia or possibly cardiac pains may be experienced. In particularly disposed patients urination disorders, nervosity, vertigo, headaches or insomnia may occur. These effects generally disappear immediately upon discontinuing administration of the drug.

Note:

If you notice side effects, stop taking Antiadipositum RIEMSER. Should you experience more severe complaints or if the complaints persist for a longer period after stopping administration, consult a physician.

Should you experience side effects that have not been listed here, please inform your physician or chemist.

Notes and details on shelf life and storing the drug

This drug should not be administered after expiry date (best used before...). Protect anti-adiposity RIEMSER from humidity.

Keep medicines out of the reach of children!