20 mg medicinal chewing gum 
dimenhydrinate

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

Always take this medicine exactly as described in this leaflet, or as instructed by your doctor, pharmacist, or nurse.

– Save this information, you may need to read it again.

– Contact the pharmacy staff if you need more information or advice.

– If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Calma is and what it is used for 
2. What you need to know before taking Calma 
3. How to take Calma 
4. Possible side effects 
5. How to store Calma 
6. Contents of the packaging and other information 

1. What Calma is and what it is used for

Calma is medical chewing gum. The active ingredient in Calma is an antihistamine that prevents and relieves nausea and vomiting in motion sickness (eg car, bus, flight, and seasickness). Please note that the doctor may have prescribed the medicine for another use and/or with a different dosage than that stated in the package leaflet. Always follow the doctor’s prescription and instructions on the label on the medicine package.

2. What you need to know before taking Calma

Do not take Calma

– if you are allergic to dimenhydrinate or any of the other ingredients of this medicine (listed in section 6).

– if you have acute asthma attacks.

– if you have porphyria (hereditary enzyme deficiency disease).

– if you have glaucoma with a narrow chamber angle ( glaucoma ).

– if you have severe prostate enlargement or severe narrowing of the urethra.

Calma contains aspartame and should therefore not be taken by people with phenylketonuria.

Warnings and cautions

If you have any of the following, talk to your doctor, pharmacist or nurse before taking Calma:

– chronic lung problems and asthma

– prostate enlargement

– narrowing of the urethra which makes it difficult to empty the bladder

– narrowing of the stomach

– seizures ( epilepsy, eclampsia )

– cardiovascular disease

– impaired renal function

– severe liver disease

– acute porphyria

– alcohol abuse

a condition called pheochromocytoma

Other medicines and Calma

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Sedatives and anti-anxiety drugs, sleeping pills, or alcohol should not be used concomitantly with Calma. There is a risk that drowsiness caused by Calma may be aggravated when combined with these medicines.

Some medicines for Parkinson’s and depression (eg so-called MAO inhibitors ) as well as so-called beta-blockers may affect or be affected by Calma. So-called anticholinergic drugs that contain atropine (found in eye drops, for example ) or ipratropium bromide (bronchodilators) can also affect the effect of Calma.

Pregnancy and breastfeeding

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.

During pregnancy, Calma should only be used after special consideration. During the last weeks of pregnancy, Calma should not be used as there is a risk that dimenhydrinate may cause contractions.

Dimenhydrinate passes into breast milk but is unlikely to affect breastfed infants. However, consult your doctor if you use Calma more than temporarily during breastfeeding.

Driving and using machines

Calma may affect the ability to drive and use machines. Calma may impair the ability to react, which should be taken into account as increased attention is required.

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.

Calma contains aspartame, lactose, glucose, sucrose, sorbitol and sodium

This medicine contains 3 mg of aspartame per chewing gum. Aspartame is a source of phenylalanine. It can be harmful if you have phenylketonuria (PKU), a rare, inherited disease that leads to the accumulation of high levels of phenylalanine in your body. See section 2 (“Do not take Calma”).

Calma contains lactose (<1 mg), glucose (10 mg) and sucrose (406 mg). If you (or your child) do not tolerate certain sugars, you should consult your doctor before using this medicine.

Calma contains 285 mg of sorbitol per chewing gum. Sorbitol is a source of fructose. 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.

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

3. How to take Calma

Always take this medicine exactly as described in this leaflet or as directed by your doctor, pharmacist, or nurse. If you are not sure, talk to your doctor, pharmacist, or nurse.

The recommended dose is:

Adults and children over 12 years: A chewing gum is chewed for at least 10 minutes. If nausea nevertheless occurs, another chewing gum can be chewed after 30 minutes. This can be repeated one more time. A piece of chewing gum should be taken about 15-30 minutes before motion sickness is expected. The effect lasts for 3-6 hours.

Maximum daily dose is 4 chewing gums. If you are not sure, talk to a pharmacist.

The chewing gum should not be swallowed.

Use for children

Calma is not recommended for use in children below 12 years due to insufficient data on safety and efficacy.

If you forget to take Calma

You can take Calma even after you become ill, see point 3 above: How to take Calma.

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

4. Possible side effects

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

Some people may experience a short-lived and transient numbness in the mouth. This is harmless and due to the local anesthetic effect of the active ingredient.

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

Uncommon (may affect up to 1 in 100 people): dry mouth and allergic skin reactions.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Calma

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

Do not store above 25 ° C.

Do not use this medicine after the expiry date which is stated on the carton and blister after “EXP” or “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 dimenhydrinate. A pack of chewing gum contains 20 mg of dimenhydrinate.
  • The other ingredients are aspartame, calcium carbonate, dextrin, dimetylaminoetylmetylmetakrylat methyl (butyl) methacrylate copolymer, gum base, hard fat, liquid glucose , macrogol, light magnesium oxide, magnesium stearate, menthol, methacrylic acid-methacrylate copolymer, montane gykolvax, peppermint flavor (containing lactose ), potassium dihydrogen phosphate, povidone, saccharin sodium, sorbitol, anhydrous colloidal silica, sucrose, talc, titanium dioxide (E171), white beeswax. Chewing gum contains 406 mg of sugar (sucrose).

What the medicine looks like and the contents of the pack

The coated chewing gum is white, biconvex, and round.

The pack sizes are 2, 10, and 20 chewing gums.

Marketing Authorisation Holder:

Meda OTC AB

Box 906

170 09 Solna

Manufacturer:

Hermes Pharma Ges.mbH, Schwimmschulweg 1a, 9400 Wolfsberg, Austria

Orifice Medical AB, Aktergatan 2, 4 and 5, 271 55 Ystad

Muhammad Nadeem

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