10 mg, 25 mg film-coated tablets
hydroxyzine hydrochloride
1. What Hydroxyzine Orifarm is and what it is used for
What is Hydroxyzine Orifarm?
Hydroxyzine Orifarm belongs to a group of medicines called sedative antihistamines. It suppresses certain functions in the brain without being addictive. It also blocks histamine, a substance found in the body’s tissues that causes allergic reactions.
What is it used for?
Hydroxyzine Orifarm is used to treat:
- anxiety in adults, where other drugs are not suitable
- hives and itching caused by allergic reactions
In case of anxiety, the effect is felt after about 15 minutes and lasts for about 12 hours. With itching and hives, the effect is reached after about 1 hour and lasts at least 24 hours.
Hydroxyzine hydrochloride contained in Hydroxyzine Orifarm may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before you take Hydroxyzine Orifarm
Do not take Hydroxyzine Orifarm
- if you are allergic to hydroxyzine hydrochloride or any of the other ingredients of this medicine (listed in section 6)
- if you are allergic to cetirizine (medicine for allergy ), aminophylline (medicine for asthma or other lung diseases), ethylenediamine (an ingredient in aminophylline) or other piperazine derivatives (closely related to other medicines)
- if you have a hereditary disease, porphyria , which is characterized by an accumulation of toxic substances (porphyrins) in the body
- if your ECG ( electrocardiogram ) shows a type of heart problem called prolonged QT interval
- if you have or have had a cardiovascular disease or if you have a very slow heart rhythm
- if you have low salt levels in your body (eg low potassium or magnesium )
- if you are taking certain medicines for heart rhythm problems or medicines that can affect your heart rhythm (see “Other medicines and Hydroxyzine Orifarm”)
- if someone in the family has died suddenly of heart problems
- if you are pregnant or breastfeeding
Warnings and cautions
Talk to your doctor, pharmacist, or nurse before taking Hydroxyzine Orifarm
- if you have kidney or liver disease. You may need a lower dose .
- if you have an increased risk of seizures
- if you have a risk factor for stroke , such as high blood pressure , smoking or obesity
- if you have increased pressure in the eye ( glaucoma )
- if you have difficulty urinating
- if you have slow bowel function
- if you suffer from severe muscle weakness ( myasthenia gravis )
- if you suffer from dementia
Hydroxyzine Orifarm may cause an increased risk of heart rhythm problems which can be life-threatening. Therefore, tell your doctor if you have any heart problems or if you are taking any other medicines, including medicines obtained without a prescription.
Contact your healthcare provider immediately if you experience heart problems such as palpitations, difficulty breathing, or unconsciousness while taking Hydroxyzine Orifarm. Treatment with hydroxyzine should be discontinued.
Dry mouth can be a side effect of Hydroxyzine Orifarm. Therefore, good oral hygiene is important during treatment with Hydroxyzine Orifarm.
If you are going to have an allergy test, you should stop taking Hydroxyzine Orifarm at least 5 days before the test. Ask your doctor for advice.
Older
Caution should be exercised if you are older, you may need a lower dose. The treatment time should be as short as possible.
Other medicines and Hydroxyzine Orifarm
Tell your doctor or pharmacist if you have recently taken or might take any other medicines, including medicines obtained without a prescription. Hydroxyzine Orifarm can affect or be affected by other medicines.
Do not take Hydroxyzine Orifarm if you are taking medicines to treat:
- bacterial infections (eg antibiotics; erythromycin, moxifloxacin, levofloxacin)
- fungal infections (eg pentamidine)
- heart problems or high blood pressure (eg amiodarone , quinidine , disopyramide , sotalol)
- psychosis is (eg haloperidol )
- depression (eg citalopram , escitalopram)
- gastrointestinal disorders (eg prucalopride)
- allergy
- malaria (eg mefloquine, hydroxychloroquine)
- cancer (eg toremifene, vandetanib)
- drug abuse or severe pain ( methadone )
Also, tell your doctor if you are taking:
- betahistine used to treat Meniere’s disease (difficulties with balance and hearing)
- phenytoin used to treat seizures
- adrenaline used to treat severe allergic reactions
- drugs used to treat anxiety or sleep problems
- anticholinergic drugs used to treat, for example, IBS (irritable bowel syndrome) and asthma
- cimetidine used to treat stomach upset. It may increase the level of Hydroxyzine Orifarm in your blood
- monoamine oxidase inhibitors ( MAOIs ) used to treat depression and Parkinson’s disease
- thiazide diuretics (used, for example, to treat high blood pressure ). They may increase the risk of irregular heartbeat.
Hydroxyzine Orifarm with food, drink and alcohol
The tablets can be taken with or without food.
You should not drink alcohol while taking Hydroxyzine Orifarm as this combination may potentiate the effects of Hydroxyzine Orifarm and thus increase the risk of side effects.
Pregnancy and breastfeeding
Pregnancy
Do not take Hydroxyzine Orifarm if you are pregnant or think you may be pregnant. Talk to your doctor if you are planning to have a baby.
Hydroxyzine, the active substance in Hydroxyzine Orifarm, passes into the fetus. There is a risk that the fetus is affected.
Breast-feeding
Do not take Hydroxyzine Orifarm if you are breastfeeding.
Discontinue breastfeeding if treatment with Hydroxyzine Orifarm is necessary. Ask your doctor for advice.
Driving and using machines
Hydroxyzine Orifarm may affect your ability to react and concentrate. Be careful when driving or handling machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased vigilance. 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.
Hydroxyzine Orifarm contains lactose
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
How to take Hydroxyzine Orifarm
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
Important: the doctor determines the dose one and adjusts it individually for you. Do not change the dose without first talking to a doctor.
Hydroxyzine Orifarm should be used at the lowest effective dose and for the shortest possible treatment time.
25 mg tablet: the tablet can be divided into two equal doses.
The recommended dose is:
Hives and itching:
- Adults and adolescents from 12 years of age: the initial dose is 1 or 2 tablets of 25 mg in the evening.
- Children aged 5-11 years: 1 tablet of 10 mg or 1 tablet of 25 mg in the evening. Your doctor will inform you about the correct dose .
See “Maximum daily dose for all indications” below.
If you / your child needs a dose lower than 10 mg or if you / your child have difficulty swallowing tablets, other medicines containing hydroxyzine may be more appropriate. Talk to a doctor.
Anxiety in adults:
- Adults : the usual dose is 1-5 tablets of 10 mg 2-3 times daily or 1-2 tablets of 25 mg 2-3 times daily. But not more than 10 tablets of 10 mg or 4 tablets of 25 mg per day.
See “Maximum daily dose for all indications” below.
The maximum daily dose for all indications :
The maximum daily dose for adults and children weighing more than 40 kg is 100 mg per day.
The maximum daily dose for children weighing up to 40 kg is 2 mg/kg per day.
Drug treatment of anxiety should only be a complement to another type of treatment. The treatment should be started, followed up, and ended by one and the same doctor.
Special patient groups:
- Elderly: for the elderly, it is recommended to start with half the recommended dose . The lowest possible dose should be chosen when treating elderly patients. The maximum daily dose for the elderly is 50 mg per day.
- Patients with renal impairment: dose one should be reduced in patients with moderate to severe kidney problems.
- Patients with hepatic impairment: in patients with reduced hepatic function, recommended a reduction in the daily dose of one.
Method of administration
The tablets should be swallowed with a sufficient amount of water. The tablets can be taken with or without food. The 25 mg tablet can be divided into two equal doses.
If you take more Hydroxyzine Orifarm than you should
If you have ingested too much medicine or especially if a child has accidentally ingested the medicine, contact a doctor, hospital, or the Poison Information Center immediately for risk assessment and advice. In the event of an overdose, symptomatic treatment may be initiated. ECG monitoring can be performed due to the risk of heart rhythm problems such as prolonged QT intervals or Torsade de Pointes.
If you forget to take Hydroxyzine Orifarm
Do not take a double dose to make up for a forgotten tablet. It depends on your dosage, whether you should take the missed dose one or whether you should take your next dose at the usual time. Ask your doctor.
If you stop taking Hydroxyzine Orifarm
If you decide not to take Hydroxyzine Orifarm anymore, your symptoms may get worse. You should talk to your doctor before stopping treatment with Hydroxyzine Orifarm.
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.
Stop taking the medicine and contact your healthcare provider immediately if you get any of the following symptoms:
- heart rhythm problems such as palpitations, difficulty breathing or unconsciousness (has been reported, occurs in an unknown number of users)
- swelling of the face, lips, tongue and / or throat, sometimes with shortness of breath or difficulty swallowing ( angioedema ) (very rare side effect that may affect up to 1 in 10,000 users)
- scattered skin rash with blisters ( acute generalized exanthematous pustulosis ), annular, red, often blistering skin rash, usually on hands and feet (erythema multiforme), mucous membranes and skin inflammations in combination with high fever ( Stevens-Johnson syndrome ) (very rare side effect that may occur in up to 1 in 10,000 users)
- severe widespread skin damage with skin detachment ( toxic epidermal necrolysis ) (has been reported, occurs in an unknown number of users)
Other side effects that may occur:
Very common: may affect more than 1 user in 10
- somnolence
Common: may affect up to 1 in 10 users
- headache
- drowsiness
- dry mouth
- fatigue
Uncommon: may affect up to 1 in 100 people
- anxiety, confusion
- dizziness, insomnia, tremors
- nausea
- malaise, fever
Rare: may affect up to 1 in 1,000 users
- allergic reactions (hypersensitivity)
- disorientation, hallucinations (see things that do not exist)
- seizures, involuntary movements
- accommodation disorders (difficulty focusing the gaze), blurred vision
- cardiac arrest, effects on heart rhythm, rapid heartbeat
- low blood pressure
- constipation, vomiting
- elevated liver enzyme levels (can be seen on blood tests)
- itching , hives, skin rash with redness , spots or blemishes, skin inflammation
- difficulty urinating
Very rare: may affect up to 1 in 10,000 people
- anaphylactic shock (potentially fatal allergic reaction )
- contractions of the respiratory tract
Has been reported: Occurs in an unknown number of users
- reduction in platelet count
- hepatitis
- aggression, depression, recurrent involuntary muscle twitching ( tics )
- abnormal elongated muscle contractions, feeling of tickling, tingling or numbness
- irregular heartbeat and ECG changes associated with it ( QT prolongation, Torsades de Pointes )
- uncontrolled circulating eye movements
- diarrhea
- bedwetting
- extreme weakness, tissue swelling caused by fluid retention ( edema )
- weight gain
- fainting
- pemphigoid (blisters on arms, legs, abdomen and mucous membranes).
Reporting of side effects
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. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Hydroxyzine Orifarm
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 carton after EXP. dat / 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 hydroxyzine hydrochloride 10 mg and 25 mg respectively
- Other ingredients are:Core : lactose monohydrate , tricalcium phosphate, pregelatinized starch , sodium lauryl sulfate, colloidal anhydrous silica, magnesium stearate.Film coating : Macrogol, hypromellose, titanium dioxide (E171)
What the medicine looks like and contents of the pack
10 mg: White to off-white, round biconvex film-coated tablet and flat on both sides (diameter 5.3–5.7 mm, thickness 2.7–3.3 mm).
25 mg: White to off-white, round biconvex film-coated tablet with the notch on one side (diameter 7.8–8.2 mm, thickness 3.5–4.1 mm).
PVC / PVDC / aluminum blisters: 25 and 100 tablets
HDPE jar: 250 tablets
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Orifarm Generics A / S
Energivej 15
5260 Odense S
Denmark
Local representative:
Orifarm Generics AB,
Box 56048
102 17 Stockholm
info@orifarm.com
This medicinal product is authorized under the European Economic Area under the names:
Denmark, Norway, Finland: Hydroxyzine Orifarm