Fadezin

Package leaflet: Information for the user

Fadezin 25 mg film-coated tablets

promethazine hydrochloride
Generic medicine
Please read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

• What Fadezin is and what it is used for
• What you need to know before taking Fadezin
• How to take Fadezin
• Possible side effects
• How to store Fadezin
• Contents of the pack and other information

1. What Fadezin is and what it is used for

Fadezin contains a medicine called promethazine hydrochloride. It belongs to a group of
medicines called phenothiazines. It works by blocking histamine, a substance naturally present
in the body that causes itching during an allergic reaction. Like many antihistamines,
it has a sedative effect.
Fadezin can be used in the following situations:

• to treat sleep disturbances
• to treat severe anxiety
• to help you feel more relaxed before surgery or a dental procedure
• to treat or prevent motion sickness (e.g. seasickness)
• to treat allergic reactions of various origins
• to treat or prevent nausea and dizziness
• to treat nervous anxiety and tension states

2. What you need to know before taking Fadezin

Do not take Fadezin

• if you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
• if you are taking a medicine for depression belonging to a group of medicines called monoamine oxidase inhibitors (MAOIs). Also, do not take Fadezin if you have stopped taking one of these MAOI medicines within the last 14 days. If you are in doubt, ask your doctor or pharmacist (see section “Other medicines and Fadezin” below). Fadezin must not be administered to children under 5 years of age.

Warnings and precautions
Talk to your doctor or pharmacist before taking Fadezin. This is particularly important if you:

• have dizziness, drowsiness, or severe headaches
• have an enlarged prostate
• have a stomach blockage or have difficulty passing urine
• have severe muscle weakness (myasthenia gravis)
• have liver problems
• are at risk of stroke
• have heart rhythm disorders

Due to dry mouth (which is a common side effect), there is a risk of dental or oral mucosal damage, especially with long-term use. Therefore, during treatment with this medicine, you should carefully brush your teeth twice daily using a fluoride toothpaste.
Treatment with Fadezin may cause problems for contact lens wearers due to dry eyes.
Taking Fadezin may affect the results of urine pregnancy tests, potentially leading to false-positive or false-negative results.
If you are unsure whether any of the above apply to you, consult your doctor or pharmacist before taking Fadezin.

Other medicines and Fadezin
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Do not take this medicine and inform your doctor or pharmacist if you are taking or have taken the following medicines within the last 2 weeks:
Some medicines for depression called monoamine oxidase inhibitors (MAOIs). If you are in doubt, consult your doctor or pharmacist.
It is also particularly important to inform your doctor or pharmacist if you are taking medicines used for:

• irritable bowel syndrome, asthma, or overactive bladder (anticholinergic medicines), as these may increase the risk of dizziness, dry mouth, and blurred vision
• heart rhythm disorders and other heart conditions (e.g. flecainide, amiodarone, quinidine, and beta-blockers)
• treatment of bacterial infections (e.g. certain antibiotics such as moxifloxacin and erythromycin)
• treatment of fungal infections (e.g. terbinafine)
• pain or medication dependence (e.g. methadone)
• prevention of malaria (mefloquine)
• intestinal disease (e.g. cisapride)
• mental disorders (e.g. lithium and neuroleptic agents such as haloperidol, clozapine, and risperidone)
• depression (e.g. tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRIs) such as paroxetine and fluoxetine)
• anxiety (e.g. diazepam)
• sleep problems (e.g. zolpidem)

Avoid concomitant treatment with certain diuretics (thiazide diuretics), as these can reduce potassium levels in the blood and thereby increase the risk of heart rhythm disturbances.

Fadezin with food, drinks, and alcohol
Do not drink alcohol while taking Fadezin.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Driving and using machines
Treatment with Fadezin may impair reaction ability. This should be taken into account in situations requiring alertness, such as driving vehicles.
These effects may also occur the following morning. Make sure you are not affected by these effects before driving vehicles or operating machinery.

Fadezin contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. it is essentially “sodium-free”.

3. How to take Fadezin

Take this medicine exactly as instructed by your doctor or pharmacist. If you
have any doubts, consult your doctor or pharmacist.
The dose will be determined by your doctor, who will tailor it to your individual needs. For doses that cannot be
achieved with Fadezin, other dosage strengths of medicinal products containing promethazine hydrochloride are available. The lowest effective dose for the shortest necessary duration should be used. Always take the dose prescribed by your doctor.
The usual dose is:
Sleep disturbances:
Adults: 25–50 mg at bedtime.
Sometimes treatment is interrupted every three or four nights.
Severe anxiety and hyperactivity:
Adults: 25–50 mg, up to 400–500 mg within 24 hours under close medical supervision.
Before a procedure or dental surgery:
Adults: 25–50 mg one hour before treatment; if necessary, the same dose may be taken the evening
before treatment.
Children from 6 to 12 years of age: 25 mg one hour before treatment; if necessary, the same dose may
be taken the evening before treatment.
Motion sickness:
Adults: 25 mg, 1–2 hours before travel, or alternatively, the evening before travel. If needed, two additional doses may be taken within 24 hours.
Allergic conditions:
Adults: 25–50 mg at bedtime.
Nausea and dizziness:
Adults: 25 mg 1–4 times daily.
Nervous anxiety and tension states:
Adults: 25–50 mg 1–3 times daily.
If you take more Fadezin than you should
If you or your child takes more Fadezin than prescribed, contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine package with you so that the doctor knows what has been taken.
If you forget to take Fadezin
Do not take a double dose to make up for the missed tablet.
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 gets them.
Stop taking Fadezin and contact your doctor or go to hospital immediately if you experience any of the following side effects:

• Liver problems which may cause yellowing of the eyes or skin (jaundice)
• Jerky movements and problems such as slowness, muscle stiffness, tremor, and feeling restless
• Very fast or irregular heartbeat or chest pain

Other possible side effects:
Common (may affect up to 1 in 10 people)

• Dry mouth
• Drowsiness. Since Fadezin is usually taken in the evening, you may feel somewhat drowsy the following morning. This effect usually disappears after a few days of treatment.

Uncommon (may affect up to 1 in 100 people)

• Dry eyes
• Difficulty focusing between near and far objects
• Constipation
• Difficulty urinating

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the Italian Medicines Agency (Agenzia Italiana del Farmaco) at the website https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Fadezin

Keep this medicine out of sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister pack and on the carton after
EXP.
The expiry date refers to the last day of that month.
Do not dispose of medicines 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 Fadezin contains
The active substance is promethazine hydrochloride. Each tablet contains 25 mg of active substance.
The other components are:
Tablet core: microcrystalline cellulose (E460), anhydrous calcium hydrogen phosphate (E341),
sodium starch glycolate, stearic acid, magnesium stearate (E470B).
Tablet coating: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), talc.
Description of the appearance of Fadezin and packaging contents
Fadezin 25 mg film-coated tablets are white, oval-shaped, biconvex tablets measuring 9.8 mm x 6.2 mm, marked with "C25" on one side and smooth on the other. They are available in blister packs (PVC/PCTFE/PVC foil and aluminum covering foil).
Pack sizes:
Blister packs:
20 or 56 film-coated tablets.
Not all pack sizes may be marketed.
Marketing Authorization Holder
S.F. Group Srl
Via Tiburtina, 1143
00156 - Roma
Italy
Manufacturer
Teva Operations Poland Sp. z.o.o
Mogilska 80 street
PL-31-546 Kraków
Poland