25 mg film-coated tablets
Hydroxyzine hydrochloride
1. What Hydroxyzine EQL Pharma is and what it is used for
What is Hydroxyzine EQL Pharma?
Hydroxyzine EQL Pharma belongs to a group of medicines called sedative antihistamines. It suppresses certain functions of the brain without creating an addiction. It also blocks histamine, a substance found in the body’s tissues that causes allergic reactions.
What is it used for?
Hydroxyzine EQL Pharma is used to treat:
- anxiety in adults where no alternative medication is indicated,
- hives ( urticaria ) and itching ( pruritus ) caused by allergic reactions in adults, adolescents and children 5 years and older.
Hydroxyzine hydrochloride contained in Hydroxyzine EQL Pharma may also be approved for the treatment of other conditions not mentioned in this product information. 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 taking Hydroxyzine EQL Pharma
Do not take Hydroxyzine EQL Pharma
- If you are allergic to the active substance (hydroxyzine hydrochloride) or any of the other ingredients of this medicine (listed in section 6).
- If you are allergic to cetirizine (medicine used to treat allergies ), aminophylline (medicine used to treat asthma or other lung diseases), ethylenediamine (a component of aminophylline) or other piperazine derivatives (closely related active substances in other medicines).
- If you have a hereditary disease ( porphyria ) that is characterized by the accumulation of toxic compounds (porphyrins) in your body.
- If you are pregnant or breastfeeding.
- 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 levels of potassium or magnesium )
- If you are taking certain medicines for heart rhythm problems or medicines that may affect your heart rhythm(see “Other medicines and Hydroxyzine EQL Pharma”)
- If someone in the family has died suddenly of heart problems
Warnings and cautions
Hydroxyzine EQL Pharma can 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 EQL Pharma. Treatment with hydroxyzine should be discontinued.
- Talk to your doctor or pharmacist before taking Hydroxyzine EQL Pharma:
- If you have a kidney disease or a liver disease or if you are older. You may need a lower dose .
- If you are at greater risk of having seizures (seizures).
- If you have any risk factors for stroke .
- If you have heart disease.
- If you have irregular heartbeat.
- If you have increased pressure in the eye ( glaucoma ).
- If you have obstructions in the urinary system.
- If you have an imbalance of salts in your body.
- If you have low levels of potassium or magnesium in your blood.
- If you have slow bowel function.
- If you have pronounced muscle weakness ( myasthenia gravis ).
- If you have mental disorders (dementia).
- Dry mouth can be a side effect of using Hydroxyzine EQL Pharma. It is therefore important that you have good oral hygiene during treatment with Hydroxyzine EQL Pharma.
- If you are undergoing allergy testing, treatment with Hydroxyzine EQL Pharma should be stopped at least 5 days before testing. Ask a doctor for advice.
- Caution is required with elderly patients. The duration of treatment should be as short as possible.
Children
Hydroxyzine EQL Pharma should not be used in children under 5 years of age.
Younger children are more susceptible to side effects related to the central nervous system, such as seizures (cramps).
Other medicines and Hydroxyzine EQL Pharma
Tell your doctor or pharmacist if you have recently taken or might take any other medicines.
Do not take Hydroxyzine EQL Pharma 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 (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 )
Hydroxyzine EQL Pharma may reduce the effects of:
- betahistine used to treat Meniere’s disease (balance and hearing problems),
- phenytoin used in the treatment of seizures (seizures),
- adrenaline used to treat severe allergic reactions.
Hydroxyzine EQL Pharma may increase the effect of:
- medicines used to treat anxiety or to help you sleep,
- anticholinergic drugs for the treatment of e.g. irritable bowel syndrome (indigestion).
Also, tell your doctor if you are taking:
- cimetidine used to treat stomach upsets. This may increase the level of Hydroxyzine EQL Pharma in the blood.
- monoamine oxidase inhibitors used to treat depression,
- other drugs that can cause severe arrhythmias (such as other neuroleptics , Class IA and III antiarrhythmic drugs, tricyclic antidepressants , selective serotonin reuptake inhibitors, lithium or cisapride),
- thiazide diuretics (used to treat high blood pressure , for example ). These may increase the risk of irregular heartbeat.
Hydroxyzine EQL Pharma and alcohol
You should not drink alcohol with Hydroxyzine EQL Pharma as this combination may increase the effects of Hydroxyzine EQL Pharma.
Pregnancy
Do not take Hydroxyzine EQL Pharma if you are pregnant, think you may be pregnant, or are planning to have a baby. Hydroxyzine, the active substance in Hydroxyzine EQL Pharma, passes into the fetus.
There is a risk that the fetus is affected.
Ask your doctor or pharmacist for advice before taking this medicine.
Breast-feeding
Do not take Hydroxyzine EQL Pharma if you are breastfeeding.
Discontinue breastfeeding if treatment with Hydroxyzine EQL Pharma is necessary.
Ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines
Hydroxyzine EQL Pharma may affect your reactions and your ability to concentrate. Be careful when driving and using machines.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened 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.
Hydroxyzine EQL Pharma 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.
3. How to take Hydroxyzine EQL Pharma
Dosage
Always take this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Hydroxyzine EQL Pharma should be used at the lowest effective dose and for the shortest possible treatment time.
Important: your doctor will determine the dose that is right for you. Your dose and when it should be taken are clearly indicated on the label that the pharmacist attaches to your medicine. Otherwise, or if you are unsure, ask your doctor or pharmacist. Do not change your dose without first consulting your doctor.
The recommended dose is:
Hives and itching of the skin:
- Adults and adolescents 12 years and older:
- The initial dose is 1 tablet (25 mg) in the evening.
- The usual dose can be increased to a maximum of 4 tablets (100 mg).
- Children 5-11 years: 1-2 mg per kg body weight per day divided into 2-3 doses .
Anxiety:
- Adults: the usual dose is 2 tablets (50 mg) divided into different doses .
Treatment of anxiety with medication should always be a supportive measure. The treatment should be started, followed up, and completed with the same doctor.
Maximum dose:
The maximum daily dose for adults and children weighing more than 40 kg is 100 mg per day. This applies to all treatments.
Special patient groups:
- Elderly: in the elderly it is advisable to start with half the recommended dose one. 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: the dose should be reduced in patients with moderate or severe renal impairment.
- Patients with hepatic impairment: in patients with hepatic impairment, a reduction of the daily dose by one third is recommended .
Use for children and adolescents
Hydroxyzine EQL Pharma is only indicated for the treatment of children 5 years and older and adolescents. The maximum daily dose for children weighing up to 40 kg is 2 mg/kg per day.
Method of administration
The tablets should be swallowed with a sufficient amount of water. The tablets can be taken with or not with food.
The tablet can be divided into equal doses.
If you take more Hydroxyzine EQL Pharma than you should
If you have ingested too much medicine or if a child, in particular, has ingested the medicine by mistake, contact the hospital or the Poison Information Center immediately for risk assessment and advice. In the event of an overdose, symptomatic treatment is 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 EQL Pharma
Do not take a double dose to make up for a forgotten tablet.
Take the next tablet at the usual time.
If you stop taking Hydroxyzine EQL Pharma
If you decide to stop taking Hydroxyzine EQL Pharma, your symptoms may worsen. Talk to your doctor before stopping treatment with Hydroxyzine EQL Pharma.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (may affect more than 1 in 10 people):
- somnolence.
Common (may affect up to 1 in 10 people):
- headache,
- fatigue,
- dry mouth ,
- sedation .
Uncommon (may affect up to 1 in 100 people):
- anxiety, confusion,
- dizziness, lack of sleep, tremors,
- nausea,
- malaise, fever.
Rare (may affect up to 1 in 1000 people):
- allergic reactions (hypersensitivity),
- disorientation, hallucinations (see things that do not exist),
- seizures, movement disorders ( dyskinesia ),
- problems focusing the eye, blurred vision,
- irregular heartbeat and associated changes in the electrocardiogram ( QT prolongation, Torsade de Pointes ), cardiac arrest, heart rate effects, rapid heartbeat ( ventricular arrhythmias , fibrillation and tachycardia ),
- low blood pressure ,
- constipation, vomiting,
- elevated liver enzyme levels ( transaminases , alkaline phosphatase, bilirubin and glutamyl),
- itching , hives, marks or blisters, inflammation of the skin ( dermatitis ),
- urinary retention .
Very rare (may affect up to 1 in 10,000 people):
- anaphylaxis (potentially fatal allergic reaction ),
- respiratory tract contractions ( bronchospasm ),
- swelling of the face, lips and / or throat, sometimes with difficulty breathing or swallowing ( angioedema ), increased sweating, rash that always appears in the same place on the skin and in connection with taking the drug (fixed drug eruption), widespread rash with blisters ( acute generalized exanthematous pustulosis ), annular, red rash, often with blisters – common on hands and feet (erythema multiforme), inflammation of the mucous membranes and skin associated with high fever ( Stevens-Johnson syndrome).
Has been reported (occurs in an unknown number of users):
- decreased platelet count ( thrombocytopenia ),
- aggression, depression, repeated involuntary muscle twitches ( tics ),
- abnormal prolonged muscle contractions ( dystonia ), tingling, tingling or numbness ( paresthesia ),
- uncontrolled circulatory eye movements (oculogyration),
- diarrhea,
- bedwetting or difficulty urinating (abnormal urination),
- extreme fatigue ( asthenia ), tissue swelling due to fluid retention ( edema ),
- weight gain.
- Stop taking the medicine and contact your healthcare provider immediately if you have heart rhythm problems such as palpitations, difficulty breathing or unconsciousness.
Children and the elderly
Children and the elderly are more susceptible to side effects.
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 EQL Pharma
Keep out of sight and reach of children.
Do not use after the expiry date which is stated on the carton and blister after 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
What Hydroxyzine EQL Pharma contains
- The active substance is hydroxyzine hydrochloride.
- Each film-coated tablet contains 25 mg of hydroxyzine hydrochloride.
- The other ingredients are anhydrous lactose , microcrystalline cellulose, anhydrous colloidal silica, magnesium stearate, hypermellose, titanium dixoid (E171) macrogol.
What Hydroxyzine EQL Pharma looks like and what the package contains
Hydroxyzine EQL Pharma is a white to off-white, oblong, biconvex film-coated tablet with a notch on both sides. Each pack contains 25 or 100 film-coated tablets in blisters.
Marketing Authorisation Holder
EQL Pharma
Stortorget 1
222 23 Lund
Manufacturer
Medreich PLC
Warwick House
Plane Tree Crescent
Feltham, TW13 7HF
UK
Or
Inpharmasci
ZI N ° 2 Prouvy – Rouvignies
1, rue de Nungesser
59121 Prouvy
France
This medicinal product is authorized in the EEA Member States under the following names:
Denmark – Hydroxyzine Hydrochloride EQL Pharma
Finland – Hydroxyzine Sandoz
Norway – Hydroxyzine EQL Pharma