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Diphenhydramine 50 mg tablets

Patient information for "Diphenhydramine"

1. What is "Diphenhydramine" and what is it used for?

1.1 What are the properties of the medicinal product?

"Diphenhydramine" contains the active ingredient diphenhydramine, a drug from the group of so-called H1 antihistamines.

Due to the blockade of central H1 receptors, these agents have a sedating and antiemetic effect and are mainly used as sedatives (sleeping pills and tranquilizers) or antiemetics (agents against nausea and vomiting).

Diphenhydramine is usually used in salt form as diphenhydramine hydrochloride.

Diphenhydramine for oral or rectal use is only available in pharmacies and without a prescription.

1.2 What strengths and dosage forms are there?

Diphenhydramine is commonly available as a

- tablets / film-coated tablets / coated tablets containing 25 or 50 mg diphenhydramine hydrochloride,

- children's suppositories containing 20 mg diphenhydramine hydrochloride,

- Suppositories containing 50 mg of diphenhydramine hydrochloride.

Your doctor or your pharmacist will advise you which strength and dosage form are suitable for your treatment.

1.3 Diphenhydramine is used

1.3.a) in adults

for the short-term treatment of sleep disorders or dizziness, nausea, vomiting, kinetoses (e.g. motion sickness).

1.3.b) in children

for the treatment of nausea and vomiting from a body weight of 8 kg.

When used in infants and young children under 3 years of age: Studies have shown that the administration of diphenhydramine to infants and young children for the treatment of banal gastroenteritis shows no benefit compared to substitution with fluids and electrolytes alone. Against the background of the increased occurrence of serious side effects in children up to 3 years of age in this indication, diphenhydramine should not be used to treat common gastroenteritis. Since diphenhydramine can trigger a seizure, especially in small children, and this group of patients is also prone to febrile seizures, diphenhydramine should not be given to febrile infections. The indication is strict for children up to 3 years of age. In this age group, the recommended maximum dose must not be exceeded under any circumstances.

2. What should you watch out for before using "Diphenhydramine"?

2.1. "Diphenhydramine" must not be used

- in case of hypersensitivity to the active substance diphenhydramine hydrochloride, to other antihistamines or to one of the other components of the drug,

- in acute asthma,

- with glaucoma (narrow-angle glaucoma),

- in certain tumors of the adrenal medulla (pheochromocytoma),

- with enlargement of the prostate gland with residual urine formation,

- in epilepsy,

- if you have a potassium or magnesium deficiency,

- if the heartbeat is slow (bradycardia),

- with certain heart diseases (congenital QT syndrome or other clinically significant cardiac damage, in particular circulatory disorders of the coronary arteries, conduction disorders, arrhythmias),

- with simultaneous use of drugs that also prolong the so-called QT interval in the ECG or lead to hypokalaemia (see under "Interactions with other drugs"),

- if you are taking alcohol or so-called "MAO inhibitors" (agents used to treat depression) at the same time,

- while breastfeeding.

2.2.Special caution is required when using "diphenhydramine",

if you have any of the following diseases:

- impaired liver function

- impaired kidney function

- chronic lung disease or asthma

- certain gastric disorders (pyloric stenosis or achalasia of the cardia).

Before starting treatment with diphenhydramine hydrochloride, any specific causes of the disease that are to be treated should be clarified (see also the note under areas of application).

Repeated use over a longer period of time can lead to a loss of effectiveness (tolerance).

The use of the active ingredient diphenhydramine hydrochloride can lead to the development of physical and emotional dependence. The risk of addiction increases with dose and duration of treatment. This risk is also increased in patients with a history of alcohol, drug or drug addiction.

Notes on other ingredients: Suppositories may contain soy proteins. Do not use this medicine or do not use this medicine on your child if they are allergic to peanuts or soy. Macrogol glycerol ricinoleate (Ph. Eur.) Can cause irritation of the mucous membranes.

2.2.a) Children and young people

Especially in infants and toddlers up to 3 years of age, the active ingredient diphenhydramine can cause serious side effects such as seizures. The indication for treatment should therefore be made strict in this patient group. Young children with simple gastrointestinal flu or febrile infections should not be treated with diphenhydramine. In these cases, however, a sufficient supply of fluids and electrolytes should be ensured.

So-called "paradoxical reactions" (restlessness, excitement, anxiety) can occur, especially in small children, during treatment with diphenhydramine. Therefore, particular caution is required in this age group and dosage should be used cautiously. Weakened children and children with impaired liver or kidney function should also be reduced Preserving doses Overdosing should be avoided at all costs in young children and these patient populations.

The recommended dosage should never be increased on your own initiative. Infants weighing less than 8 kg should not be treated with children's suppositories (20 mg).

There is insufficient experience with the efficacy and tolerability of diphenhydramine as a sleeping aid in children and adolescents.

2.2.b) Elderly patients

In elderly or debilitated patients who may be particularly sensitive, it is recommended that the dose be adjusted if necessary.

2.2.c) Pregnancy

"Diphenhydramine" should not be used during pregnancy, especially not in the last few weeks of pregnancy because of the risk of premature labor. If necessary, ask your doctor or pharmacist if you want to use diphenhydramine for nausea and vomiting during pregnancy.

2.2.d) Breastfeeding

"Diphenhydramine" must not be used during breastfeeding.

2.2.e) Ability to drive and use machines

The active ingredient diphenhydramine hydrochloride, even when used as intended, can change the ability to react to such an extent that the ability to actively drive or operate machines is impaired. Therefore, no vehicles may be driven or dangerous machines operated. On the following day, residual tiredness and impaired reactions or reduced ability to concentrate can still have a detrimental effect on the ability to drive or work with machines, especially after insufficient sleep or in combination with alcohol.

2.3 Interactions with other medicinal products

Please inform your doctor or pharmacist if you are taking / using or have recently taken / used any other medicines, including medicines obtained without a prescription.

Diphenhydramine hydrochloride must not be given together with so-called "MAOIs" (certain medicines used to treat depression).

The simultaneous use of "diphenhydramine" with other drugs that also contain diphenhydramine, including those that are used externally, should be avoided.

Simultaneous use with other central depressant drugs such as sleeping pills, sedatives, painkillers or anesthetics, anti-anxiety drugs (anxiolytics), drugs for the treatment of depression or drugs for the treatment of seizure disorders (antiepileptics) can lead to mutual reinforcement.

The so-called "anticholinergic" effect of diphenhydramine can be enhanced by drugs with a similar effect such as atropine, biperiden, tricyclic antidepressants or monoamine oxidase inhibitors. An increase in intraocular pressure, urinary retention or possibly life-threatening intestinal paralysis can occur.

Taking diphenhydramine with medicines to lower blood pressure can make you feel more tired.

Simultaneous use with drugs that also prolong the so-called QT interval in the ECG, e.g. agents against cardiac arrhythmias (antiarrhythmics class IA or III9), certain antibiotics (e.g. erythromycin), cisapride, anti-malarial agents, agents against allergies or gastric / Intestinal ulcers (antihistamines) or agents for the treatment of special mental and emotional disorders (neuroleptics), or with agents that can lead to a potassium deficiency (e.g. certain diuretics), should be avoided.

Diphenhydramine can possibly falsify the test results in allergy tests and should therefore not be used at least 3 days beforehand.

2.4.When using "diphenhydramine" with food and beverages

During treatment with "diphenhydramine", alcohol must not be drunk, as this changes and intensifies the effect of diphenhydramine in an unforeseeable way.

3. How should "Diphenhydramine" be used?

Always use "Diphenhydramine" exactly as your doctor has told you or in accordance with the package insert. Please ask your doctor or pharmacist if you are not sure.

3.1 Type and duration of application

The tablets / film-coated tablets as sleeping pills are swallowed whole in the evening 30 minutes before going to bed with some liquid (water). You should then be able to sleep adequately (7 to 8 hours).

The rectal capsules / suppositories must be inserted into the rectum with the thick end first (possibly after slightly moistening with a little water). As a result, the rectal capsules slide more easily into the intestine and undesired sliding out can be prevented.

To prevent motion sickness, the application should take place at least 30 minutes before departure.

There should be an interval of at least 4 to 6 hours between the administration of two single doses.

The duration of treatment should be as short as possible. In general, it should only be a few days and not exceed 2 weeks. If the symptoms persist, please consult a doctor immediately.

When stopping treatment with tablets, sleep disturbances due to sudden discontinuation may recur temporarily. Therefore, you should stop treatment by gradually reducing the dose.

3.2 Unless otherwise prescribed by the doctor, the usual dose is

3.2.a) Adults

3.2.a.1.Short-term treatment of sleep disorders

Adults take 50 mg diphenhydramine hydrochloride 30 minutes before going to bed. This dose should not be exceeded. The duration of treatment should be as short as possible. In general, it should only last a few days and not exceed 2 weeks.

3.2.a.2. Prevention and treatment of nausea and vomiting

50 mg 1 to 3 times a day (corresponding to 50 to 150 mg diphenhydramine hydrochloride per day) as tablets or suppositories. There should be an interval of at least 4 to 6 hours between the administration of two single doses.

One dose per day should initially be used to prevent nausea and vomiting. If acute symptoms occur, the dose can be increased to the maximum daily dose according to age, with an interval of at least 4 to 6 hours between the individual doses.

To prevent motion sickness, the application should take place at least 30 minutes before departure.

3.2.b) Patients with impaired liver or kidney function

should receive lower doses.

3.2.c) Children and adolescents for the prevention and treatment of nausea and vomiting

3.2.c.1. Suppositories in children weighing 8 kg or more

Overdosing with the active ingredient diphenhydramine hydrochloride can be life-threatening, especially in children under 3 years of age and must therefore be avoided at all costs, especially in this age group. Therefore, never give your toddler more than 3 mg / kg body weight in 24 hours.

The recommended dosage should never be increased on your own initiative! There should be an interval of at least 4 to 6 hours between the administration of two single doses. The following recommendations apply:

- Small children with a body weight of 8 to 16 kg: 1 rectal capsule containing 20 mg once a day (corresponding to a maximum of 20 mg diphenhydramine hydrochloride per day)

- Small children with a body weight of 16 to 21 kg: 1 rectal capsule with 20 mg once or twice a day (corresponding to a maximum of 40 mg diphenhydramine hydrochloride per day)

- Children from 6 years with and over 21 kg body weight: 1 rectal capsule 1 to 3 times with 20 mg daily (corresponding to max. 60 mg diphenhydramine hydrochloride per day)

To prevent motion sickness, the application should take place at least 30 minutes before departure.

Weakened children and children with impaired liver or kidney function should receive lower doses than those indicated above.

To prevent nausea and vomiting, you should first use one rectal capsule / suppository per day. If acute symptoms occur, the dose can be increased to a maximum of 2 rectal capsules per day (children 3 to 6 years) or to a maximum of 3 rectal capsules per day (children from 6 years of age), with an interval of at least 4-6 hours between the individual doses should be adhered to.

3.2.c.2.Tablets for children from 6 years of age

- Children from 6 to 12 years of age receive 25 mg diphenhydramine hydrochloride (equivalent to ½ tablet) a maximum of 2 times a day.

- Children over 12 years of age and adolescents receive 50 mg diphenhydramine hydrochloride (equivalent to 1 tablet) a maximum of 2 times a day.

To prevent nausea and vomiting, the lowest single dose per day should be taken according to age. If acute symptoms occur, the dose can be increased to the maximum daily dose according to age, with a time interval of at least 4-6 hours between the individual doses.

3.3.If you use more "diphenhydramine" than you should

Diphenhydramine overdoses can be dangerous, especially to children and young children. For this reason, if you suspect an overdose or poisoning, a doctor must be informed immediately (e.g. poisoning emergency number)!

Overdoses with diphenhydramine are primarily expressed depending on the amount absorbed by disorders of the central nervous system (confusion, states of excitement up to seizures, clouded consciousness up to coma, breathing disorders up to respiratory arrest) and the cardiovascular system. In addition, increased muscle reflexes, fever, dry mucous membranes, visual disturbances, constipation and disorders of urinary excretion can occur.

Rhabdomyolysis (severe muscle damage) has also been observed.

4. What are the possible side effects?

Like all medicines, "diphenhydramine" can have side effects, although not everybody gets them.

When evaluating side effects, the following frequencies are used as a basis:

- very common: more than 1 in 10 people

- common: less than 1 in 10, but more than 1 in 100 patients

- uncommon: less than 1 in 100, but more than 1 in 1,000 patients

- rarely: less than 1 in 1,000 but more than 1 in 10,000 people treated

- very rare: less than 1 in 10,000 patients, including isolated cases

- Frequency not known: frequency cannot be calculated from the available data

4.1 Which side effects can occur in detail?

The following side effects are to be expected especially at the beginning of treatment:

The most commonly reported side effects are drowsiness, drowsiness and difficulty concentrating during the following day, especially after insufficient sleep, as well as dizziness and muscle weakness.

Other more common side effects are headache, gastrointestinal complaints such as nausea, vomiting or diarrhea and so-called "anticholinergic effects" such as dry mouth, increased heart rate (tachycardia), constipation, heartburn, visual disturbances or urination problems.

Certain cardiac arrhythmias may also occur during treatment (prolongation of the QT interval in the ECG).

Hypersensitivity reactions, increased skin sensitivity to light, changes in the blood count, increased intraocular pressure, liver dysfunction (cholestatic jaundice) and so-called "paradoxical reactions" such as restlessness, nervousness, agitation, anxiety, tremors or sleep disorders have also been reported.

If the active substance diphenhydramine hydrochloride is administered for a longer period than intended, the development of drug dependency cannot be ruled out.For this reason, the need for further treatment should be critically checked after two weeks of use at the latest.

4.2 What countermeasures should be taken if side effects occur?

Let your doctor know if you experience any side effects. He will decide on possible measures.

If you experience a sudden or severe side effect, inform a doctor immediately, as certain drug side effects (e.g. excessive drop in blood pressure, hypersensitivity reactions) can under certain circumstances have serious consequences. In such cases, do not continue to take the medicine without doctor's advice.

Tell your doctor or pharmacist if you notice any side effects not listed here or in the package insert. 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 provide more information on the safety of this medicine.

5. How should "Diphenhydramine" be stored?

Store the medicine at normal room temperature and keep the medicine in the original packaging, protected from light and moisture, unless the manufacturer says otherwise.

Medicines should generally be kept out of the reach of children.

Do not use the medicine after the expiry date stated on the pack.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer need. This measure helps to protect the environment.

6. Source and processing status

Information from the SCHOLZ database based on the data approved by the Federal Office for Drugs and Medical Devices

Copyright by ePrax GmbH, Munich; January 2018 (4)