Xamamina for motion sickness

Package leaflet: Information for the patient

XAMAMINA TRAVEL SICKNESS 50 mg soft capsules, Children 25 mg soft capsules, 25 mg medicated chewing gum

Dimenhydrinate
Please read this leaflet carefully before taking this medicine because it contains important information for you.
Always take this medicine exactly as described in this leaflet or as your doctor or pharmacist has instructed you.

• Keep this leaflet. You may need to read it again.
• If you need more information or advice, consult your pharmacist.
• If any side effects occur, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.
• Consult your doctor if you do not notice improvement or if your symptoms worsen after a short period of treatment.

Contents of this leaflet:

1. What XAMAMINA TRAVEL SICKNESS is and what it is used for
2. What you need to know before taking XAMAMINA TRAVEL SICKNESS
3. How to take XAMAMINA TRAVEL SICKNESS
4. Possible side effects
5. How to store XAMAMINA TRAVEL SICKNESS
6. Contents of the pack and other information

1. What XAMAMINA TRAVEL SICKNESS is and what it is used for

XAMAMINA TRAVEL SICKNESS contains the active substance dimenhydrinate, which belongs to the class of antiemetic (anti-vomiting) and anti-nausea medicines.
XAMAMINA TRAVEL SICKNESS is used to treat motion sickness, such as sea sickness, air sickness, car sickness, and train sickness.
Consult your doctor if you do not notice any improvement or if your symptoms worsen after a short period of treatment.

2. What you need to know before taking XAMAMINA MOTION SICKNESS

Do not take XAMAMINA MOTION SICKNESS

• if you are allergic to dimenhydrinate, to other antihistamines, or to any of the other ingredients of this medicine (listed in section 6).
• during pregnancy and breastfeeding. XAMAMINA MOTION SICKNESS is contraindicated in children under 2 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking XAMAMINA MOTION SICKNESS.
If you are being treated with ototoxic medicines (those causing ear damage), you should take this medicine with caution, as it may mask symptoms of ear toxicity.
If you have narrow-angle glaucoma (increased pressure inside the eye), prostate enlargement (prostatic hypertrophy), urinary retention (difficulty urinating), slowed intestinal transit (constipation), bronchial asthma, epilepsy, or porphyria (a rare inherited disease), you should take this medicine with caution.

Children
Do not use in children under 2 years of age.

Other medicines and XAMAMINA MOTION SICKNESS
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Be cautious when taking the following medicines at the same time:

• other central nervous system depressants such as alcohol, barbiturates (medicines for depression), other hypnotics (medicines that induce sleep), sedatives or tranquilizers, since concomitant use may increase sedative effects.
• other anticholinergic medicines, including antidepressants, as concomitant use may increase their effects.
• aminoglycoside antibiotics or other ototoxic medicines, as dimenhydrinate may mask early symptoms of ear toxicity, which may only become apparent when the damage is irreversible (see section "Warnings and precautions").

XAMAMINA MOTION SICKNESS and alcohol
This medicine may enhance the effects of alcohol. In such cases, be cautious, as sedative effects may increase.

Pregnancy and breastfeeding
XAMAMINA MOTION SICKNESS is contraindicated during pregnancy and while breastfeeding.

Driving and using machines
This medicine, like other antihistamines, may cause drowsiness as an undesirable effect. If you experience such effects, take care when performing tasks requiring alertness, such as driving vehicles or operating machinery.

XAMAMINA MOTION SICKNESS contains:

• the soft capsules contain sorbitol. If your doctor has diagnosed you with an intolerance to certain sugars, consult him/her before taking this medicine.
• the soft capsules also contain ethyl parahydroxybenzoate sodium (E215) and propyl parahydroxybenzoate sodium (E217), which may cause allergic reactions (including delayed reactions).

3. How to take XAMAMINA MOTION SICKNESS

Take this medicine exactly as stated in this leaflet or as instructed by your
doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
XAMAMINA MOTION SICKNESS 50 mg soft capsules
The recommended dose is:

• Adults: 1 soft capsule half an hour before travelling; if necessary, repeat the dose after 3–4 hours, up to a maximum of 4 soft capsules in 24 hours.

The soft capsule must not be chewed, but swallowed whole, even without water.
XAMAMINA MOTION SICKNESS Children 25 mg soft capsules
The recommended dose is:

• Children aged 2–6 years: 1 soft capsule of XAMAMINA MOTION SICKNESS Children half an hour before travelling, up to a maximum of 3 times in 24 hours.
• Children aged 7–12 years: 1–2 soft capsules of XAMAMINA MOTION SICKNESS Children half an hour before travelling, up to a maximum of 2–3 times in 24 hours.

The soft capsule must not be chewed, but swallowed whole, even without water.
XAMAMINA MOTION SICKNESS Children 25 mg soft capsules must not be used in children under 2 years of age.
Do not exceed the recommended doses without medical advice.
Consult your doctor if symptoms occur repeatedly or if you have noticed any recent change in their characteristics.
Use only for short-term treatment.
If you take more XAMAMINA MOTION SICKNESS than you should
In case of accidental ingestion/overdose of XAMAMINA MOTION SICKNESS,
contact your doctor immediately or go to the nearest hospital.
The most common symptom in case of overdose is drowsiness. Toxic doses may
cause seizures, coma, and respiratory problems.
If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
When using antihistamines, the following may occur: drowsiness, sleepiness, dry mouth, light sensitivity, visual disturbances, urinary difficulties, headache, loss of appetite, nausea, skin allergic reactions.
Less frequently: dizziness, feeling of weakness, insomnia (especially in children), euphoria, tremors, convulsions (especially in children), decreased blood pressure, increased heart rate.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store XAMAMINA MOTION SICKNESS

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after Exp.
XAMAMINA MOTION SICKNESS soft capsules: store at a temperature not exceeding 25 °C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What XAMAMINA MOTION SICKNESS contains
XAMAMINA MOTION SICKNESS 50 mg soft capsules

• The active substance is dimenhydrinate. Each soft capsule contains: 50 mg of dimenhydrinate.
• The other components are: macrogol 400. Capsule shell: gelatin; sorbitol liquid, partially dehydrated; ethyl parahydroxybenzoate sodium (E215); propyl parahydroxybenzoate sodium (E217).

XAMAMINA MOTION SICKNESS Children 25 mg soft capsules

• The active substance is dimenhydrinate. Each soft capsule contains: 25 mg of dimenhydrinate.
• The other components are: macrogol 400. Capsule shell: gelatin; sorbitol liquid, partially dehydrated; ethyl parahydroxybenzoate sodium (E215); propyl parahydroxybenzoate sodium (E217).

Description of the appearance of XAMAMINA MOTION SICKNESS and contents of the pack
It is presented as soft capsules.
XAMAMINA MOTION SICKNESS 50 mg soft capsules: Carton pack containing 2, 6, or 10 capsules.
XAMAMINA MOTION SICKNESS Children 25 mg soft capsules: Carton pack containing 6 capsules.

Marketing Authorization Holder
Dompé farmaceutici S.p.A. Via San Martino 12 - 20122 Milan

Manufacturers
XAMAMINA MOTION SICKNESS soft capsules:
Catalent Italy S.p.A. – Via Nettunense Km 20,100 – Aprilia (LT)
Bracco s.p.a. - Via Caduti di Marcinelle, 13 20134 Milan

XAMAMINA MOTION SICKNESS medicated chewing gum:
Famar Italia S.p.A. - Via Zambeletti – 20021 Baranzate (MI)
Bracco s.p.a. - Via Caduti di Marcinelle, 13 20134 Milan