oral solution 
diphenhydramine hydrochloride

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor or pharmacist. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Desentol is and what it is used for 
2. What you need to know before you use Desentol 
3. How to use Desentol 
4. Possible side effects 
5. How to store Desentol 
6. Contents of the packaging and other information 

1. What Desentol is and what it is used for

Desentol is used for various types of allergic reactions such as hives, hay fever, or allergic pruritus.

Desentol contains an antihistamine (diphenhydramine) that counteracts and alleviates allergic symptoms. Diphenhydramine also has a calming effect. Desentol also contains ammonium chloride which has a weak expectorant effect.

2. What you need to know before you use Desentol

Do not use Desentol:

  • if you are allergic to diphenhydramine hydrochloride or any of the other ingredients of this medicine (listed in section 6).
  • if you have increased pressure in the eye ( glaucoma ).
  • concomitantly with certain antipsychotics (tricyclic antidepressants) and atropine-like drugs (anticholinergics).
  • to infants under 1 year.

Warnings and cautions

Talk to your doctor or pharmacist before using Desentol if you have:

  • narrowing of the urinary tract
  • enlarged prostate
  • narrowing of the lower abdomen
  • the disease myasthenia gravis (severe muscle weakness)
  • impaired liver or kidney function

Desentol can cause dry mouth during regular use, so to avoid tooth damage, it is therefore important to brush your teeth with fluoride toothpaste twice daily.

Desentol can cause dry eyes with regular use, using contact lenses can cause damage to the cornea of ​​the eye. 
Cases of abuse in connection with the use of the active substance diphenhydramine have been reported. The risk of abuse is greater in patients who have previously had drug abuse.

Other medicines and Desentol

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

Some heart and blood pressure medications (eg metoprolol ), some antidepressants ( venlafaxine ), and some other medicines may affect or be affected by treatment with Desentol. Concomitant treatment with certain sedatives can aggravate the fatigue or drowsiness that Desentol causes.

Desentol with alcohol

Alcohol exacerbates the side effects of Desentol. Therefore, alcohol should not be consumed during treatment with Desentol.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

No adverse effects on the fetus have been demonstrated. However, use during pregnancy should be done with caution. Therefore, always consult a doctor before using

Desentol during pregnancy.

Desentol passes into breast milk. Desentol should therefore not be used during breast-feeding.

Driving and using machines

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

Desentol contains sorbitol

This medicine contains 426 mg sorbitol per ml.

Sorbitol is a source of fructose. If you (or your child) do not tolerate certain sugars, or if you (or your child) have been diagnosed with hereditary fructose intolerance, a rare, inherited disease that prevents you from breaking down fructose, consult your doctor before using this medicine.

Sorbitol may cause gastrointestinal discomfort and may have a mild laxative effect.

Desentol contains macrogol glycerol hydroxy stearate

May cause stomach upset and diarrhea.

Desentol contains sodium

This medicine contains less than 1 mmol (23 mg) sodium per ml, ie essentially ‘sodium-free’.

3. How to use Desentol

Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.

Dose one is determined by the doctor, who adjusts it individually for you.

The recommended dose for adults is 10 ml 2-4 times daily.

The recommended dose for children 11-12 years (30-40 kg) is 5 ml 3-5 times daily.

The recommended dose for children 6-10 years (20-30 kg) is 5 ml 2-4 times daily.

The recommended dose for children 3-5 years (15-20 kg) is 2.5 ml 2-4 times daily.

The recommended dose for children 1-2 years (10-15 kg) is 1 ml 2-4 times daily.

If you take more Desentol than you should

If you have ingested too much medicine or if e.g. If a child has inadvertently ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice.

4. Possible side effects

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

Common (may affect up to 1 in 10 people):

  • drowsiness
  • dry mouth.

Has been reported (occurs in an unknown number of users):

  • diversion
  • ringing in the ears ( tinnitus ),
  • fatigue
  • inability to coordinate movements ( ataxia )
  • visual impairment
  • double vision
  • the feeling of well-being ( euphoria )
  • nervousness
  • tremors
  • irregular heartbeat
  • constipation
  • urinary tract disorders

5. How to store Desentol

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 bottle after EXP. The expiration date is the last day of the specified month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

– The active substance is diphenhydramine hydrochloride 3.72 mg/ml.

– Other excipients are ammonium chloride, macrogol glycerol hydroxy stearate, sodium citrate, citric acid, sorbitol, saccharin sodium, licorice essence, anise oil and purified water.

What the medicine looks like and the contents of the pack

Clear colorless to slightly yellow solution.

Packaging: 250 ml in a brown glass bottle

Marketing Authorisation Holder

Meda AB

Box 906

170 09 Solna

Phone: 08-630 1900

Manufacturer

Unimedic AB, Box 91, 864 21 Matfors

Muhammad Nadeem

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