Package leaflet: Information for the user

Prometazina Day Zero 25 mg film-coated tablets

promethazine hydrochloride
Generic medicine
Please read this leaflet carefully before 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 other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Prometazina Day Zero is and what it is used for

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

to treat sleep disorders
to treat severe anxiety
to help you feel more relaxed before surgery or a dental procedure
to treat and 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 Prometazina Day Zero

Do not take Prometazina Day Zero

if you are allergic to promethazine hydrochloride 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 Prometazina Day Zero 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 Prometazina Day Zero” below). Prometazina Day Zero must not be administered to children under 5 years of age.

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

have severe dizziness, drowsiness or 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 problems
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 fluoride toothpaste.

Treatment with Prometazina Day Zero may cause problems for contact lens wearers due to eye dryness.
Taking Prometazina Day Zero may affect the results of urine pregnancy tests, possibly leading to false-positive or false-negative results.
If you are unsure whether any of the above conditions apply to you, consult your doctor or pharmacist before taking Prometazina Day Zero.
Other medicines and Prometazina Day Zero
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
Do not take this medicine and inform your doctor or pharmacist if you are taking or have taken any of 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.
Also, it is 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 drug 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 may reduce potassium levels in the blood and thereby increase the risk of heart rhythm disturbances.
Prometazina Day Zero with food, drinks and alcohol
Do not drink alcohol while taking Prometazina Day Zero.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Driving and using machines
Treatment with Prometazina Day Zero may impair reaction ability. This should be taken into account when alertness is required, for example when 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.
Prometazina Day Zero contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per tablet, i.e. essentially ‘sodium-free’.

3. How to take Prometazina Day Zero

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 Prometazina Day Zero, 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 aged 6 to 12 years: 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 Prometazina Day Zero than you should
If you or your child take more Prometazina Day Zero than prescribed, contact your doctor immediately or go to the nearest hospital emergency department.
Take the medicine pack with you so the doctor knows what has been taken.
If you forget to take Prometazina Day Zero
Do not take a double dose to make up for a forgotten 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 Prometazina Day Zero and contact your doctor or go to hospital immediately if you notice 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 Prometazina Day Zero is usually taken in the evening, you may feel somewhat drowsy the following morning. This effect disappears after a few days of treatment.

Uncommon (may affect up to 1 in 100 people)

Dry eyes
Difficulty focusing vision between near and far
Constipation
Difficulty urinating

Reporting of side effects
If you get any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the Italian Medicines Agency at the following website: 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 Promethazine Day Zero

Keep this medicine out of the 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 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 Prometazina Day Zero contains

The active substance is promethazine hydrochloride. Each tablet contains 25 mg of active substance.
The other components are: Tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate dihydrate (E341), sodium starch glycolate, stearic acid, magnesium stearate (E470B). Film coating: hypromellose (E464), macrogol (E1521), titanium dioxide (E171), talc.

Description of the appearance of Prometazina Day Zero and contents of the pack
Prometazina Day Zero 25 mg film-coated tablets are white, oval-shaped, 9.8 x 6.2 mm, biconvex tablets, marked with "C25" on one side and smooth on the other. They are available in blister packs (PVC/PCTFE/PVC sheet and aluminum foil lid).
Pack sizes
Blister packs:
20 or 56 film-coated tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Day Zero ehf.
Reykjavíkurvegi 62,
Hafnarfjördur 220,
Iceland

Manufacturer
Teva Operations Poland Sp. z o.o
Mogilska 80
PL-31-546 Kraków
Poland