VALOCORDIN-D

VALOCORDIN-Doxylamine oral drops

Important notes (mandatory information)

Valocordin-Doxylamin, drops for oral administration. Active ingredient: Doxylamine succinate. Areas of application: for the treatment of occasional sleep disorders (difficulty falling or staying asleep) in adults. Warning: Contains 55% alcohol by volume!

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Valocordin-Doxylamin 25 mg/ml drops for oral administration, solution for adults
Active ingredient: Doxylamine succinate

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 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 even worse, talk to your doctor.

What is in this package leaflet

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

1. WHAT IS VALOCORDIN-DOXYLAMIN AND WHAT IS IT USED FOR?

Valocordin-Doxylamin, an antihistamine, is used for the short-term treatment of sleep disorders. Valocordin-Doxylamin is used to treat occasional sleep disorders (difficulty falling or staying asleep) in adults. Note: Not all sleep disorders require drug therapy. They are often an expression of physical or mental illness and can be influenced by other measures or treatment of the underlying disease. Therefore, in the case of persistent sleep disorders, Valocordin-Doxylamin should not be taken for a long period of time, but the attending physician should be consulted.

2. WHAT SHOULD YOU CONSIDER BEFORE TAKING VALOCORDIN- DOXYLAMIN?

Valocordin-Doxylamin must not be taken:

• if you are allergic to doxylamine succinate or any of the other ingredients of this medicine listed in section 6,
• if you are hypersensitive to other antihistamines,
• in acute asthma attack,
• in narrow-angle glaucoma (increased intraocular pressure),
• in congenital long QT syndrome,
• in adrenal gland tumor (pheochromocytoma),
• in enlargement of the prostate gland (prostate hypertrophy) with residual urine,
• in acute poisoning by alcohol, sleeping pills or pain relievers and psychotropic drugs (neuroleptics, tranquilizers, antidepressants, lithium),
• in epilepsy,
• in concomitant treatment with monoamine oxidase inhibitors.

This medicine contains peppermint oil and must not be used in patients with bronchial asthma or other respiratory diseases associated with pronounced hypersensitivity of the respiratory tract. Inhalation of Valocordin-Doxylamin can lead to shortness of breath or trigger an asthma attack.

Warnings and precautions

Please talk to your doctor or pharmacist before taking Valocordin-Doxylamin. Special care is required when taking Valocordin-Doxylamin:

• in impaired liver function,
• in heart failure and high blood pressure,
• in chronic respiratory problems and asthma,
• in gastroesophageal reflux (reflux of stomach fluid into the esophagus),
• in certain gastrointestinal disorders (pyloric stenosis or cardia achalasia).

Children and adolescents

There is only limited experience from clinical studies in children and adolescents under 18 years of age. Special care is required when using Valocordin-Doxylamin in patients with neurologically recognizable brain damage in the cerebral cortex and a history of seizures, as even small doses of the medicine can trigger major epileptic seizures.

Taking Valocordin-Doxylamin with other medicines

Tell your doctor or pharmacist if you are taking/using, have recently taken/used or plan to take/use any other medicines.

• The concomitant use of other centrally acting medicines (such as psychotropic drugs, sleeping pills, pain relievers, anesthetics, antiepileptics) with Valocordin-Doxylamin can lead to a mutual reinforcement of the effect.
• the combination with procarbazine and other antihistamines can lead to a mutual reinforcement of the central depressant effect and should therefore be used with caution.
• Alcohol must not be consumed during treatment with doxylamine succinate, as this changes and intensifies the effect of doxylamine succinate in an unpredictable way.
• Results of a study in mice showed an increase in enzyme activity in the liver (cytochrome P450 enzymes, CYP2B, CYP3A, CYP2A), which are involved in the metabolism of the drug. The induction of these enzymes can lead to increased metabolism of other drugs taken concomitantly, which can lead to a reduction in their effectiveness.
• The anticholinergic effect of doxylamine succinate can be increased by the concomitant administration of other substances with anticholinergic effects (e.g. biperiden, a medicine for the treatment of Parkinson's disease; tricyclic antidepressants) in nic
• The use of medicines for high blood pressure (such as guanabenz, clonidine, alpha-methyldopa) together with Valocordin-Doxylamin can lead to increased fatigue and lassitude.
• The concomitant use of ototoxic medicines (e.g. aminoglycoside antibiotics, salicylates, some diuretics) with antihistamines can mask the symptoms of ear damage, such as tinnitus, dizziness, vertigo
• The result of skin tests can be falsified under therapy with doxylamine (false negative).
• Epinephrine should not be administered together with Valocordin-Doxylamin (vasodilation, drop in blood pressure, accelerated heart rate).
• Photosensitizing effects may be increased if other medicines with photosensitizing effects are taken at the same time.

Taking Valocordin-Doxylamin with food, drink and alcohol

Alcohol consumption should be avoided during the use of Valocordin-Doxylamin.

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

Valocordin-Doxylamin should only be taken during pregnancy on the express instructions of a doctor.

Breastfeeding

Since the active ingredient passes into breast milk, breastfeeding should be discontinued for the duration of treatment.

Driving and operating machinery

Even when used as intended, this medicine can alter reactions to such an extent that the ability to actively participate in road traffic or to operate machinery is impaired. This applies to an even greater extent in conjunction with alcohol. You will then no longer be able to react quickly and purposefully enough to unexpected and sudden events. Do not drive a car or other vehicles! Do not operate electrical tools or machinery! Do not work without a secure hold! Please note in particular that alcohol further impairs your ability to drive!

Valocordin-Doxylamin contains ethanol (alcohol)

This medicine contains 55% alcohol by volume. This is up to 900 mg per dose, equivalent to 21.87 ml of beer or 9.11 ml of wine. A health risk exists for liver patients, alcoholics, epileptics, patients with organic brain diseases, pregnant women, nursing mothers and children.

3. HOW SHOULD VALOCORDIN-DOXYLAMIN BE TAKEN?

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. Unless otherwise prescribed by your doctor, the recommended dose is: Unless otherwise prescribed, adults take 22 drops of Valocordin-Doxylamin (equivalent to 25 mg doxylamine succinate). In the case of more severe sleep disorders, a maximum dose of up to 44 drops of Valocordin-Doxylamin (equivalent to 50 mg doxylamine succinate) can be taken. The maximum daily dose should not be exceeded. To determine the individual Valocordin-Doxylamin dose, patients with impaired liver or kidney function, elderly or weakened patients who are particularly sensitive to doxylamine should consult a doctor.

Method of administration

For oral use. The drops are taken with sufficient liquid (water) approx. 1/2 to 1 hour before going to bed. It is important to ensure that there is sufficient sleep after taking Valocordin-Doxylamin in order to avoid impaired reactions the following morning.

Duration of use

The duration of treatment with Valocordin-Doxylamin should generally be only a few days and should not exceed 2 weeks. In the case of acute sleep disorders, treatment should be limited to single doses if possible. If Valocordin-Doxylamin is taken over a longer period of time, the dose should be gradually reduced at the latest 14 days after the first use in order to reassess the need for treatment. Please talk to your doctor or pharmacist if you have the impression that the effect of Valocordin-Doxylamin is too strong or too weak.

If you have taken more Valocordin-Doxylamin than you should

An overdose can be recognized by the fact that it initially leads to central symptoms such as restlessness, increased muscle reflexes, unconsciousness, depression of respiration and cardiovascular arrest
can come. Other signs of an overdose are dilated pupils, rapid heart rate (tachycardia), fever, hot, red skin and dry mucous membranes. If these symptoms occur, a doctor must be consulted immediately. Rhabdomyolysis (severe muscle damage) has also been observed. In the event of an overdose, gastric lavage with activated charcoal is recommended as an immediate measure. Depending on the clinical picture, appropriate measures should be taken in the event of gastrointestinal complaints, central nervous disorders, dry mouth, voiding disorders (micturition disorders) and visual disturbances.

If you forget to take Valocordin-Doxylamin

Do not take double the dose if you have forgotten the previous dose, but continue taking it as prescribed by your doctor or as described in the dosage instructions.

If you stop taking Valocordin-Doxylamin

There are no special features to be observed.

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 cause side effects, although not everybody gets them. The following categories are used as a basis for the frequency of side effects

The following categories are used as a basis for the frequency of 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

Depending on the sensitivity of the individual patient and the dose taken, the following side effects may occur

Blood and lymphatic system disorders

Blood cell damage can occur in very rare cases.

Endocrine disorders

In patients with adrenal gland tumor (pheochromocytoma), the administration of antihistamines can lead to an increased release of catecholamines, which have a very strong effect on the heart
Cardiovascular system.

Psychiatric disorders

Prolonged reaction time, concentration disorders, depression, fatigue, drowsiness. In addition, there is the possibility of so-called "paradoxical" reactions such as restlessness, agitation, tension, insomnia, nightmares, confusion, hallucinations, tremors. In rare cases, seizures of the brain can occur. After prolonged daily use, sleep disorders can recur with increased intensity if therapy is stopped suddenly.

Addiction

As with other hypnotics, taking doxylamine succinate can lead to the development of physical and psychological dependence. The risk of dependence increases with the dose and duration of treatment and is additionally increased in patients with a history of alcohol, drug or drug dependence.

Rebound insomnia

Sleep disorders can also recur temporarily if doxylamine succinate is discontinued after a shorter period of treatment. It is therefore recommended to end the treatment by gradually reducing the dose if necessary.

Anterograde amnesia

Even in therapeutic doses, hypnotics can cause anterograde amnesia, especially during the first few hours after taking them. This risk increases with increasing doses, but can be reduced by a sufficiently long and uninterrupted sleep (7-8 hours).

Nervous system disorders

Dizziness, drowsiness, headache. In rare cases, seizures of the brain can occur.

Eye disorders

Accommodation disorders, increased intraocular pressure.

Ear and labyrinth disorders

Tinnitus.

Heart disorders

Acceleration of the heartbeat, irregularity of the heartbeat, drop or rise in blood pressure and increase in existing heart failure can occur. ECG changes have been observed.

Respiratory, thoracic and mediastinal disorders

Impairment of respiratory function can occur due to thickening of mucus and obstruction or narrowing of the bronchi.

Gastrointestinal disorders

Accompanying effects on the autonomic nervous system such as dry mouth, constipation, nausea, vomiting, diarrhea, loss of appetite or increased appetite, pain in the stomach area can occur. Very rarely, life-threatening intestinal paralysis can occur.

Hepatobiliary disorders

Hepatic function disorders (cholestatic jaundice) have been reported during therapy with antihistamines.

Skin and subcutaneous tissue disorders

Allergic skin reactions and photosensitivity of the skin have been reported during therapy with antihistamines, as well as disorders of body temperature regulation.

Musculoskeletal, connective tissue and bone disorders

Muscle weakness.

Renal and urinary disorders

Urination disorders.

General disorders and administration site conditions

Stuffy nose, fatigue, lassitude.

Tolerance development

After repeated administration of sedatives/hypnotics, a loss of efficacy (tolerance) can occur.

Notes

Careful and individual adjustment of the daily doses can reduce the frequency and extent of side effects. The risk of side effects is greater in elderly patients, and this can also increase the risk of falls in this group of people.

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. Pharmacovigilance Kurt-Georg-Kiesinger Allee 3 D-53175 Bonn Website: www.bfarm.de by reporting side effects you can help to provide more information about the safety of this medicine.

5. HOW SHOULD VALOCORDIN-DOXYLAMIN 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 label after "Use by:". The expiry date refers to the last day of the month indicated.

Storage conditions

This medicinal product does not require any special storage conditions.

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.

Note on shelf life after opening

Valocordin-Doxylamin has a shelf life of 6 months after opening.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Valocordin-Doxylamin contains

The active ingredient is: Doxylamine