| Anafranil 10 mg coated tablets |
| Anafranil 25 mg coated tablets |
| Anafranil Retard 75 mg prolonged-release tablet is |
| clomipramine hydrochloride |
What Anafranil is and what it is used for
Anafranil affects the uptake of substances that regulate the transmission of nerve impulses in the brain. This transmission of impulses is likely to be disrupted in certain types of depression and in anxiety.
Anafranil is used for depression, nervous compulsions (eg fear of bacilli), anxiety in special situations (eg fear of squares), and attacks of unexplained panic. Also used in narcolepsy, which is a morbid condition with sudden sleep attacks.
What you need to know before taking Anafranil
Do not take Anafranil:
- If you are hypersensitive to clomipramine or any of the other ingredients of this medicine (listed in section 6), or if you are hypersensitive to tricyclic antidepressants belonging to the so-called dibenzazepine group.
- If you are taking antidepressants from the group of monoamine oxidase inhibitors ( MAOIs ), selective serotonin reuptake inhibitors ( SSRIs ), or selective serotonin and norepinephrine reuptake inhibitors ( SNRIs ).
- If you have recently had a heart attack.
Warnings and cautions
If you have or have had the following illnesses or problems, you should consult your doctor before starting treatment with Anafranil.
- epileptic seizures
- irregular heartbeat or other problems with your heart
- schizophrenia or other mental illness
- elevated pressure inside the eye ( glaucoma )
- a liver and/or kidney disease
- deviating blood values
- difficulty urinating ( urinary retention ) or prostate enlargement
- overactivity of the thyroid gland
- extensive alcohol consumption
- recurrent constipation
- an adrenal medullary tumor (eg pheochromocytoma ).
Anafranil may cause bleeding in the skin and mucous membranes. Therefore, inform your doctor if you are prone to bleeding or if you are being treated with other medicines that increase the risk of bleeding, such as medicines that inhibit the blood’s ability to coagulate. Salicylic acid products and certain anti-inflammatory drugs ( NSAIDs ).
It is important that your doctor checks you regularly to determine if your medication dose is correct and to make sure that as few side effects as possible occur. This can lead to blood sampling, blood pressure measurement, and examination of heart function.
Anafranil can cause dry mouth, which can increase the risk of cavities. You should therefore take extra care with dental hygiene and go to your dentist regularly if Anafranil treatment is prolonged.
Anafranil may reduce tear flow. In combination with contact lenses, the reduced tear flow can cause damage to the cornea of the eye. If you wear contact lenses and your eyes feel irritated, consult your doctor.
Before surgery and dental care, inform your treating physician and your dentist, respectively, that you are taking Anafranil.
Anafranil can make you particularly sensitive to sunlight. Avoid direct sunlight, protect your skin with clothing, and wear sunglasses.
Like other medicines of this type, Anafranil does not provide immediate relief of symptoms, but generally only after a few weeks. Sometimes the symptoms of depression or other mental illnesses may include thoughts of harming oneself or committing suicide. It is possible that these symptoms will continue or worsen until you have the full antidepressant effect of the medicine. Contact a doctor as soon as possible or see the nearest hospital if you have painful thoughts or experiences at any time during treatment.
If you start to feel worse and have thoughts of harming yourself
You who are depressed and/or suffer from worry/anxiety may sometimes have thoughts of harming yourself or committing suicide. These symptoms may worsen when you start using antidepressants, as it takes time for this type of medicine to take effect, usually about 2 weeks, sometimes longer.
These thoughts may be common:
- if you have previously had thoughts of harming yourself or committing suicide
- if you are younger than 25 years. Studies have shown that young adults (younger than 25 years) with mental illness who are treated with antidepressant drugs have an increased risk of suicidal thoughts and thoughts of harming themselves.
Contact a doctor as soon as possible or see the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It may be helpful to tell a relative or close friend that you are depressed and/or suffering from anxiety. Feel free to ask them to read this leaflet. You can also ask them to tell you if they think you are feeling worse or if they think your behavior is changing.
Elderly patients
Elderly patients generally need a lower dose than patients in other age groups. Anafranil should be used with caution in elderly patients and the dose should be increased carefully.
Children and young people
Anafranil should not be used in the treatment of children and adolescents under 18 years of age. Studies of other antidepressants have shown a risk of side effects such as suicide attempts, suicidal ideation, and hostility in patients under 18 years of age. This risk may also be present for Anafranil. Despite this, Anafranil can be prescribed by a doctor to patients under 18 years of age, if the doctor deems it appropriate. If you are under 18 years of age and want to discuss why you have been given this medicine, consult your doctor again.
You should also inform your doctor if you notice any of the above symptoms or if the symptoms worsen.
The long-term effects on growth, maturity, intellectual functions, and behavioral development have not yet been established for children and adolescents under 18 years of age.
Other medicines and Anafranil
Anafranil may affect the effectiveness of other medicines that you take. Before starting Anafranil treatment Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Because several medications interact with Anafranil, it is possible that the dosage of one of the other medications you are using may need to be changed and any medication you may need to stop taking. It is especially important to know if you are taking any of the following medicines:
Antidepressants containing moclobemide, fluvoxamine, fluoxetine, or paroxetine medicines used to treat high blood pressure or heart problems containing clonidine or quinidine, medicines for epilepsy containing phenobarbital or valproic acid, certain painkillers and/or antitussives containing codeine or morphine, neuroleptics(certain sedatives or sleeping pills such as levomepromazine) or medicines that inhibit the blood’s coagulation capacity such as anticoagulants (eg warfarin), salicylic acid products or so-called NSAIDs for rheumatism and inflammation, if you are taking medicines for stomach ulcers containing cimetidine and diuretics, medicines used to lower blood fats (colestipol, cholestyramine), and grapefruit/grapefruit juice or cranberry juice
It is also important to tell your doctor that you are taking Anafranil in case you need adrenaline (acute asthma and/or allergy remedy), dopamine (cardiac pacemaker after heart surgery), or norepinephrine.
If you smoke and your smoking habits change, it can lead to a change in the effect of Anafranil.
Anafranil with food and drink
Anafranil can be taken with or without food.
Pregnancy, breastfeeding, and fertility
There is a risk that the fetus is affected. The active substance in Anafranil passes into breast milk.
Therefore, always consult a doctor before using Anafranil during pregnancy and breast-feeding.
Driving and using machines
Anafranil may cause drowsiness, impaired observation, or blurred vision in some patients. If you experience symptoms of this kind, do not drive or use any tools or machines or do anything that requires increased attention.
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.
Anafranil contains lactose, sucrose and macrogolglycerol hydroxystearate
- Lactose: Anafranil tablets contain lactose monohydrate. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Anafranil tablets.
- Sucrose: Anafranil tablets contain sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Anafranil tablets.
- Macrogolglycerol hydroxy stearate: Anafranil prolonged-release tablets contain macrogol glycerol hydroxy stearate which may cause stomach upset and diarrhea.
3. How to take Anafranil
Always take this medicine exactly as your doctor has told you. Do not medicate more often or in larger doses or for a longer period of time than your doctor has prescribed. Ask your doctor or pharmacist if you are unsure.
The attending physician prescribes a dose that is individually adjusted for each patient. The dose size can vary greatly from patient to patient. Age, the disease to be treated and the severity of the disease are factors that affect the size of the dose. Treatment is usually started with a lower daily dose than the final treatment dose. At the end of treatment, the dose is often reduced gradually to avoid withdrawal symptoms in the form of nausea, bowel movements, tremors, sweating, sleep disturbances, irritability, and general malaise.
The effective treatment dose usually varies between 25 and 150 mg/day.
Anafranil tablets should be swallowed whole with a large amount of liquid. Anafranil Retard prolonged-release tablets should be swallowed whole or divided with a large amount of liquid, they must not be crushed or chewed. Anafranil can be taken with or without food.
If you forget to take Anafranil
Do not take a double dose to make up for a forgotten dose.
If you forget to take an Anafranil dose, take the missed dose as soon as possible and then return to your usual dose. If it is soon time for the next dosing session, do not take the missed dose but continue dosing one as usual. If you have any further questions, ask your doctor.
If you stop taking Anafranil
Contact your doctor before stopping Anafranil.
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. The side effects usually do not require medical treatment and often subside spontaneously during the continued treatment when the body gets used to the medication.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Very common side effects (affects more than 1 patient in 10):
Dizziness, tremors, headache, muscle contractions, visual disturbances, blurred vision, nausea, dry mouth, constipation, difficulty urinating, potency disorders, fatigue, increased appetite, weight gain, sweating, restlessness.
Common side effects (affects more than 1 patient in 100):
Agitation, anxiety, aggression, confusion, insomnia, concentration problems, nightmares, memory loss, personality changes, concentration problems, muscle weakness, pupil dilation, tinnitus, palpitations, flushing, nausea, vomiting, stomach upset, diarrhea, taste changes, rash, pruritus, photosensitivity reactions, urinary difficulties, sweating, yawning, milk secretion, swollen breasts in men, drop in blood pressure in connection with sudden standing or sitting up, decreased appetite.
Uncommon side effects (affects more than 1 user in 1,000):
Seizures, difficulty coordinating muscle movements, irregular heartbeat.
Rare side effects (affects less than 1 user in 1,000):
Glaucoma ( glaucoma ), gastrointestinal bleeding (severe stomach pain), jaundice, swelling by an accumulation of fluid, skin redness, hair loss, hemorrhages in the skin and mucosa, allergic reactions, fever.
Very rare (affects less than 1 patient in 10,000):
Malignant neuroleptic syndrome (muscle stiffness, fever, unconsciousness)
No known frequency (can not be calculated from the available data): Serotonergic syndrome (causes symptoms such as agitation, confusion, diarrhea, high body temperature, increased blood pressure, sweating, and rapid heartbeat), difficulty sitting still, involuntary movements, muscle breakdown (as a complication of the malignant neuroleptic syndrome), thoughts of harming oneself, committing suicide, increased levels of prolactin (a hormone ) in the blood, delayed or absent ejaculation of semen.
An increased risk of bone fractures has been seen in patients taking this type of drug.
Contact your doctor as soon as possible if you experience the following side effects that may require medical attention: yellowing of the skin, skin reactions ( itching or reddening of the skin), fever and stiffness in the throat, balance disorders, eye pain, severe abdominal pain, muscle weakness or stiffness, muscle cramps, urination difficulties ( urinary retention ), swollen breasts and milk secretion, fast or irregular heartbeat, speech difficulties, confusion, hallucinations, seizures.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. How to store Anafranil
Keep this medicine out of the sight and reach of children.
Anafranil 10 mg tablets and Anafranil Retard 75 mg prolonged-release tablets do not have any special storage instructions. Anafranil 25 mg tablets should be stored in the original package. Moisture sensitive.
Do not use this medicine after the expiry date which is stated on the carton 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
- The active substance is clomipramine hydrochloride.
- The other ingredients in the coated tablets are glycerol (85%) (25 mg tablet), hypromellose, copovidone, lactose monohydrate 33 mg (10 mg tablet) resp. 15 mg (25 mg tablet), macrogol, magnesium stearate, corn starch, microcrystalline cellulose, povidone, iron oxide (dye E172), sucrose, stearic acid (25 mg tablet), talc, titanium dioxide (dye E171), anhydrous colloidal silica.
- The other ingredients in the release tablets are Eudragit ED (copolymer of polyacrylic / metaakrylestrar), hydrogenated castor oil (Polyoxyl 40 saturated castor oil), hypromellose, calcium stearate, calcium hydrogen phosphate, iron oxide (colorant E 172), anhydrous colloidal silica, talc, titanium dioxide (color E 171).
What the medicine looks like and the contents of the pack
Coated tablet 10 mg: 5.8 mm high, 3.3 mm thick, light yellow, triangular, biconvex
Coated tablet 25 mg: 5.5 mm light yellow, round, biconvex
Prolonged-release tablet 75 mg: pink, oblong with a notch, marked CG and GD
Anafranil 10 mg coated tablets are supplied in packs of 30, 100 coated tablets.
Anafranil 25 mg coated tablets are supplied in packs of 30, 100 coated tablets.
Anafranil Retard 75 mg prolonged-release tablets are supplied in packs of 20, 100 prolonged-release tablets .
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Novartis Sverige AB, Box 1218, 164 28 Kista