vivinox Sleep Strong - 20 tablets

Vivinox Sleep strong sleeping tablets. Active ingredient: Diphenhydramine hydrochloride. Indications: Vivinox Sleep strong sleeping tablets are used for the short-term treatment of sleep disorders. Warnings: Contains lactose.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Vivinox Sleep strong sleeping tablets, for the short-term treatment of sleep disorders in adults.

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 experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
• If you do not feel better or even feel worse, consult your doctor.

What this leaflet contains:

1. WHAT ARE VIVINOXSLEEP STRENGTH SLEEPING TABLETS AND WHAT ARE THEY USED FOR?
2. WHAT SHOULD YOU KEEP IN MOST CONSIDER BEFORE TAKING VIVINOXSLEEP SLEEPING TABLETS?
3. How should Vivinox Sleep sleeping tablets be taken as a strong dose?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How should Vivinox Sleep Strong sleeping tablets be stored?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT ARE VIVINOX SLEEP STRENGTH SLEEPING TABLETS AND WHAT ARE THEY USED FOR?

Vivinox Sleep Strong sleeping tablets are a sleep aid from the antihistamine group. Vivinox Sleep Strong sleeping tablets are used for the short-term treatment of sleep disorders.

2. WHAT SHOULD YOU KNOW BEFORE TAKING VIVINOX SLEEP STRENGTH SLEEPING TABLETS?

Vivinox Sleep Strong sleeping tablets must not be taken:

• if you are allergic to diphenhydramine hydrochloride, other antihistamines or any of the other ingredients of this medicine listed in section 6,
• (in certain tumors of the adrenal medulla, pheochromocytoma),
• in cases of enlarged prostate gland with residual urine formation,
• in cases of urinary retention,
• in epilepsy,
• in case of potassium or magnesium deficiency,
• in cases of slowed heart rate (bradycardia),
• in certain heart diseases (congenital QT syndrome or other clinically significant heart damage, especially coronary artery disease, conduction disorders, arrhythmias),
• when used concurrently with drugs that also prolong the so-called QT interval in the ECG (e.g., class IA or III antiarrhythmics, antibiotics, antimalarials, neuroleptics, serotonin reuptake inhibitors such as citalopram, escitalopram) or lead to hypokalemia (e.g., certain diuretics),
• when taken at the same time as alcohol or so-called MAO inhibitors (medicines for the treatment of depression),
• in children and adolescents under 18 years of age,
• during pregnancy or while breastfeeding,
• Severe intolerances may occur when taking Vivinox Sleep sleeping tablets in cases of acute asthma, narrow-angle glaucoma, enlarged prostate gland, adrenal gland tumor, stomach and/or duodenal ulcers, as well as in cases of narrowed gastrointestinal passage and narrowing of the bladder outlet.

Warnings and precautions:
Please talk to your doctor or pharmacist before taking Vivinox Sleep Strong sleeping tablets.

Special care should be taken when taking Vivinox Sleep Strong sleeping tablets if you suffer from any of the following conditions:

• impaired liver function,
• chronic lung diseases or asthma,
• certain stomach dysfunctions (pyloric stenosis or achalasia of the cardia).

Vivinox Sleep Strong sleeping tablets should only be used after consulting a doctor.

Repeated use of sleeping pills over a prolonged period can lead to a loss of effectiveness (tolerance).

As with other sleeping pills, taking Vivinox Sleep Strong can lead to the development of physical and psychological 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 medication dependence.

When stopping treatment with Vivinox Sleep Strong, sleep disturbances may temporarily recur if the medication is discontinued abruptly. Therefore, it is recommended that treatment be discontinued, if necessary, by gradually reducing the dose.

Children and adolescents:
There is insufficient experience regarding the efficacy and tolerability of diphenhydramine as a sleeping pill in children and adolescents. Therefore, Vivinox Sleep Strong should not be prescribed to children and adolescents.

Taking Vivinox Sleep sleeping tablets with other medicines:
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

The effects of the following medicines may be significantly altered if taken at the same time as Vivinox Sleep sleeping tablets:

• Vivinox Sleep strong sleeping tablets should not be taken together with so-called MAO inhibitors (certain medications for the treatment of depression).
• The simultaneous use of Vivinox Sleep sleeping tablets with other drugs that also contain diphenhydramine, including those applied externally, should be avoided.
• The simultaneous use with other centrally acting depressants, such as sedatives, tranquilizers, painkillers or anesthetics, with anxiolytics, with drugs for the treatment of depression or with drugs for the treatment of seizure disorders (antiepileptics) can lead to a mutual potentiation of the effects.
• The so-called anticholinergic effects of diphenhydramine can be intensified by drugs with similar effects, such as atropine, biperiden, tricyclic antidepressants, or monoamine oxidase inhibitors. This can lead to an increase in intraocular pressure, urinary retention, or, in some cases, life-threatening paralytic ileus.
• The use of Vivinox Sleep sleeping tablets strongly in combination with blood pressure lowering drugs can lead to increased tiredness.
• Simultaneous use with drugs that also prolong the so-called QT interval in the ECG, e.g., drugs for cardiac arrhythmias (antiarrhythmics class IA or III), certain antibiotics (e.g., erythromycin), cisapride, antimalarials, drugs for allergies or stomach/intestinal ulcers (antihistamines), or drugs for the treatment of specific mental illnesses (neuroleptics or serotonin reuptake inhibitors, such as citalopram or escitalopram), or with drugs that can lead to potassium deficiency (e.g., certain diuretics), should be avoided.

Other possible interactions:
Diphenhydramine may interfere with allergy test results and should therefore not be used for at least 3 days beforehand.

Taking Vivinox Sleep Strong sleeping tablets with alcohol:
You must not drink alcohol while using Vivinox Sleep Strong sleeping tablets, as this can unpredictably alter and intensify the effects of diphenhydramine.

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 using this medicine.

Pregnancy:
Vivinox Sleep Strong sleeping tablets must not be used during pregnancy.

Breastfeeding:
Diphenhydramine, the active ingredient in Vivinox Sleep Strong sleeping tablets, passes into breast milk. Therefore, sedation in the breastfed infant cannot be ruled out during breastfeeding. For this reason, Vivinox Sleep Strong sleeping tablets must not be taken while breastfeeding.

Elderly people:
Vivinox Sleep Strong sleeping tablets should only be taken by elderly people after consulting their doctor, as they may be more sensitive to side effects, especially anticholinergic side effects. The likelihood of side effects increases with impaired liver or kidney function and through interactions with other medications taken/used concurrently.

Driving and operating machinery:
Even when used as directed, Vivinox Sleep Strong sleeping tablets can impair reaction time to such an extent that the ability to actively participate in road traffic is affected. The same applies to the ability to operate tools or machinery and to perform hazardous activities. Even the following day, residual drowsiness and impaired reaction time can still adversely affect the ability to drive or operate machinery, especially after insufficient sleep.

Vivinox Sleep Strong sleeping tablets contain lactose. Please only take Vivinox Sleep Strong sleeping tablets after consulting your doctor if you know that you suffer from an intolerance to certain sugars.

3. HOW TO TAKE VIVINOX SLEEP STRENGTH SLEEPING TABLETS?

Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

Unless otherwise prescribed by your doctor, the recommended dose is:

Adults:
1 tablet (equivalent to 50 mg diphenhydramine hydrochloride). This dose should not be exceeded.

Patients with impaired liver or kidney function should receive lower doses.

It is also recommended that the dose be adjusted as necessary for elderly or debilitated patients, who may be particularly sensitive.

Method of administration:
Tablets for oral use.

Please swallow the tablets whole with sufficient liquid (preferably a glass of water) 30 minutes before bedtime. Sufficient sleep duration (7 to 8 hours) should then be ensured.

Duration of use:
The duration of treatment should be as short as possible. It should generally only last a few days and should not exceed 2 weeks. If sleep disturbances persist, please consult a doctor!

Please talk to your doctor or pharmacist if you feel that the effect of Vivinox Sleep sleeping tablets is too strong or too weak.

If you have taken more Vivinox Sleep sleeping tablets than you should:
Overdoses of diphenhydramine, as well as ingestion by children and infants, can be dangerous. Therefore, if an overdose or poisoning is suspected, a doctor should be informed immediately (e.g., contact the poison control center)!

Overdoses of diphenhydramine primarily manifest themselves – depending on the amount ingested – through disturbances of the central nervous system (confusion, agitation up to seizures, impaired consciousness up to coma, respiratory distress up to respiratory arrest) and the cardiovascular system. Increased muscle reflexes, fever, dry mucous membranes, visual disturbances, constipation, and urinary retention may also occur. Rhabdomyolysis (severe muscle damage) has also been observed.

If you have forgotten to take Vivinox Sleep sleeping tablets:
Do not take a double dose to make up for a missed dose. Instead, continue taking the tablets as described in the dosage instructions or as prescribed by your doctor.

If you stop taking Vivinox Sleep sleeping tablets abruptly:
When stopping treatment with Vivinox Sleep sleeping tablets abruptly, sleep disturbances may temporarily recur. Therefore, it is recommended to end treatment by gradually reducing the dose (see section 2).

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS

The following frequency categories are used to describe side effects:
Very common (= 1/10)
Common (= 1/100, < 1/10)
Uncommon (= 1/1,000, < 1/100)
Rare (= 1/10,000, < 1/1,000)
Very rare (< 1/10,000)

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

The following side effects are particularly likely to occur at the start of treatment:
The most frequently reported side effects are drowsiness, dizziness, difficulty concentrating the following day, especially after insufficient sleep, as well as vertigo and muscle weakness.

Other common side effects include headache, skin reactions, gastrointestinal problems such as nausea, vomiting or diarrhea, and so-called anticholinergic effects such as dry mouth, constipation, heartburn, visual disturbances or difficulty urinating.

During treatment with Vivinox Sleep strong sleeping tablets, certain heart rhythm disorders may occur (prolongation of the QT interval on the ECG). Hypersensitivity reactions, increased photosensitivity of the skin, changes in blood count, increased intraocular pressure, jaundice (cholestatic jaundice), and so-called paradoxical reactions such as restlessness, nervousness, agitation, anxiety, tremors, or sleep disturbances have also been reported.

Please inform your doctor or pharmacist if any of the listed side effects become serious or if you notice any side effects not listed in this leaflet.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this 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, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE VIVINOX SLEEP STRENGTH SLEEPING TABLETS?

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and blister. The expiry date refers to the last day of that month.

Do not store above 25°C. Store in the original package in order to protect from light and moisture.

Never dispose of this medicine via wastewater (e.g., not down the toilet or sink). Ask your pharmacist how to dispose of the medicine when you no longer need it. This will help protect the environment. Further information can be found at: www.bfarm.de/arzneimittelentsorgung.

6. CONTENTS OF THE PACK AND OTHER INFORMATION.

What Vivinox Sleep Strong sleeping tablets contain:

The active ingredient is:
Diphenhydramine. 1 tablet contains 50 mg of diphenhydramine hydrochloride as the active ingredient.

The other ingredients are:
Microcrystalline cellulose, lactose, povidone (K 25), silicon dioxide, magnesium stearate (Ph. Eur.), crospovidone.

How Vivinox Sleep Strong sleeping tablets look and contents of the pack:
White, round tablet with a score line.

(Apo) Usually ship out within 3-5 business days