BETADORM

BETADORM D tablets

Important notes (mandatory information)

Betadorm-D 50 mg Tablets. Active ingredient: Diphenhydramine hydrochloride. Areas of application: for short-term treatment of sleep disorders.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Betadorm-D 50 mg Tablets
Active ingredient: Diphenhydramine hydrochloride

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

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If you get 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 after 14 days, contact your doctor.

What this package leaflet contains

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

1. WHAT IS BETADORM-D AND WHAT IS IT USED FOR?

Betadorm-D is a sleeping pill from the group of antihistamines. Betadorm-D is taken for the short-term treatment of sleep disorders. Betadorm-D is for use in adults.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING BETADORM-D?

Betadorm-D must not be taken:

• if you are allergic to diphenhydramine, other antihistamines or any of the other ingredients of this medicine listed in section 6.
• if you have an acute asthma attack.
• if you have glaucoma.
• if you have certain tumors of the adrenal medulla (pheochromocytoma).
• if you have an enlarged prostate with residual urine.
• if you have epilepsy.
• if you have potassium or magnesium deficiency.
• if you have a slow heart rate.
• if you have certain heart conditions (congenital QT syndrome or other heart damage, especially coronary artery disease, conduction disorders, arrhythmias).
• if you are taking medicines at the same time that also cause certain conduction disorders in the heart (prolong the QT interval on the ECG) (see section "Interactions with other medicines")
• if you are taking medicines at the same time that lead to a reduced potassium level in the blood (see section "Interactions with other medicines").
• if you are taking MAO inhibitors (medicines for treating depression) at the same time (see section "Interactions with other medicines").
• if you are drinking alcohol at the same time.
• if you are pregnant or breastfeeding.
• if you are under 18 years old.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Betadorm-D:

• if you have impaired liver function.
• if you have chronic lung diseases, certain respiratory diseases such as emphysema, chronic bronchitis or asthma.
• if you have a narrowing of the stomach outlet (pyloric stenosis).
• if you have a disorder of the lower esophageal sphincter (achalasia of the cardia).
• with repeated use of sleeping pills over a longer period of time. There may be a loss of effectiveness.
• because taking Betadorm-D can lead to excitability.
• because taking Betadorm-D or other sleeping pills can lead to the development of physical and mental dependence. The risk of dependence increases with the dose and duration of treatment. This risk is also increased in patients with a history of alcohol, drug or drug addiction.
• when stopping treatment with Betadorm-D. Abrupt discontinuation can cause sleep disorders to temporarily recur. Therefore, you should end the treatment by gradually reducing the dose.

Children and adolescents

There is insufficient experience with the efficacy and tolerability of diphenhydramine as a sleeping pill in children and adolescents. Therefore, Betadorm-D should not be used in children and adolescents under 18 years of age.

Taking Betadorm-D 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.

Do not take Betadorm-D at the same time as the following medicines:

• other medicines that also contain diphenhydramine, including those that are applied externally.
• other centrally depressant medicines, such as sleeping pills, sedatives, pain relievers or anesthetics, anxiolytics (anxiolytics), medicines for treating depression or seizures (antiepileptics). There may be a mutual reinforcement of the effect.
• active ingredients such as atropine, biperiden, tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors). The so-called "anticholinergic effect" of diphenhydramine can be increased by these substances. Increased intraocular pressure, urinary retention or, in some cases, life-threatening intestinal paralysis may occur.
• blood pressure lowering medicines. Increased fatigue may occur.
• medicines that can cause certain conduction disorders in the heart (prolongation of the so-called QT interval on the ECG), e.g. antiarrhythmics (antiarrhythmics class IA or III), certain antibiotics (e.g. erythromycin), cisapride, antimalarials, anti-allergy or gastrointestinal ulcer medicines (antihistamines) or medicines for treating special mental illnesses (neuroleptics).
• medicines that can lead to potassium deficiency (e.g. certain diuretics).

Diphenhydramine may falsify test results in allergy tests. Therefore, do not take Betadorm-D for at least 3 days before.

Taking Betadorm-D with food, drink and alcohol

You must not drink alcohol during treatment with Betadorm-D, as this changes and intensifies the effect of diphenhydramine in an unpredictable way.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before taking this medicine. You must not take Betadorm-D during pregnancy and breastfeeding.

Driving and using machines

After taking Betadorm-D, you must not drive a vehicle or operate tools or machines. Even on the following day, noticeable drowsiness and impaired responsiveness can still have a negative effect on driving ability or the ability to work with machines, especially after insufficient sleep or in combination with alcohol.

3. HOW TO TAKE BETADORM-D?

Always take this medicine exactly as described in this package leaflet or exactly as agreed with your doctor or pharmacist. Check with your doctor or pharmacist if you are not sure. The recommended dose is: Adults take 1 tablet (equivalent to 50 mg diphenhydramine hydrochloride). Single dose = total daily dose. You should not exceed the total daily dose. If you have impaired liver or kidney function, the dose of Betadorm-D is too high for you. In this case, you should take a medicine with a lower dosage. In elderly or weakened patients who may be particularly sensitive, it is also recommended to adjust the dose if necessary.

Method of administration

Take the tablet in the evening 30 minutes before going to bed with sufficient liquid (preferably 1 glass of water). You should then sleep sufficiently (7 - 8 hours).

Duration of use

The duration of treatment should be as short as possible. It should generally only be a few days and should not exceed 2 weeks. Please talk to your doctor or pharmacist if you have the impression that the effect of Betadorm-D is too strong or too weak.

If you have taken more Betadorm-D than you should

Overdoses of diphenhydramine can be dangerous - especially for children and toddlers. In case of suspected overdose or poisoning, inform a doctor immediately (e.g. poison control center)! Overdoses of diphenhydramine depend on the amount taken. Primarily, disorders of the cardiovascular system and the central nervous system (confusion, anxiety, hallucinations, delirium, psychoses, states of excitement up to seizures, clouding of consciousness up to coma, respiratory disorders up to respiratory arrest) can occur. In addition, increased muscle reflexes, fever, hot flashes, dry mucous membranes, visual disturbances, constipation, reduced bowel sounds, drowsiness, slight high blood pressure, nausea, vomiting, impaired urination and metabolic acidosis may occur. Rhabdomyolysis (severe muscle damage) and impaired kidney function have also been observed.

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
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

Very common:

• Calming, sleepiness

Common:

• Drowsiness, dizziness and difficulty concentrating during the following day, especially after insufficient sleep
• Dizziness, muscle weakness, weakness
• Headaches, visual disturbances
• dry throat, dry mouth
• Gastrointestinal complaints (nausea, vomiting, diarrhea), heartburn, stomach pain, constipation
• Difficulty urinating

Uncommon:

• Tinnitus
• Skin rash

Rare:

• Changes in the blood count
• Hypersensitivity reactions
• Jaundice
• so-called "paradoxical reactions" such as restlessness, nervousness, irritability, excitement, anxiety, confusion, tremors or sleep disorders

Not known:

• Lowering of blood pressure, palpitations, rapid heartbeat, certain heart rhythm disorders (prolongation of the QT interval on the ECG)
• Coordination difficulties, cramps, sensory disturbances
• Blurred vision, increased intraocular pressure
• Itching, hives, increased sensitivity of the skin to light
• Chest discomfort
• dry nose
• Upper abdominal discomfort
• Urinary retention
• Hallucinations

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, Pharmacovigilance Department, 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 BETADORM-D?

Keep this medicine out of the reach of children. Do not use this medicine after the expiry date which is stated on the carton after "Use by". The expiry date refers to the last day of the month indicated. Do not store above 30°C. Do not dispose of medicines in wastewater or household waste. 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 Betadorm-D contains

The active ingredient is: Diphenhydramine hydrochloride. 1 tablet contains 50 mg diphenhydramine hydrochloride. The other ingredients are: microcrystalline cellulose, pregelatinized starch (potato starch), cellulose powder, magnesium stearate (Ph. Eur.) [vegetable], talc, highly dispersed silicon dioxide.

What Betadorm-D looks like and contents of the pack

Betadorm-D are white round tablets. Betadorm-D is packed in PVC/Al blisters and is available in packs of 10 and 20 tablets.

Pharmaceutical entrepreneur

Recordati Pharma GmbH
Eberhard-Finckh-Str. 55
89075 Ulm
Phone: (0731) 7047-0
Fax: (0731) 7047-297

Manufacturer

Lusomedicamenta - Sociedade Técnica Farmacêutica, S. A.
Estrada Consiglieri Pedroso 69 B
Queluz de Baixo
2730-055 Barcarena
Portugal

This leaflet was last revised in September 2013.

Source: Information from the package leaflet
Status: 01/2018
Active ingredient: Diphenhydramine hydrochloride. Areas of application: for short-term treatment of sleep disorders.