25 mg film-coated tablets
nortriptyline
What Sensaval is and what it is used for
Sensaval belongs to a group of medicines called tricyclic antidepressants. Sensaval affects the uptake of the substances that regulate the transfer between nerve cells in the brain. Disorders in the transmission of impulses in the brain are considered an important factor in the development of depression.
Sensaval is used to treat depression.
Nortriptyline contained in Sensaval may also be approved for the treatment of other conditions not mentioned in this leaflet. Ask your doctor, pharmacist, or another healthcare professional if you have any further questions, and always follow their instructions.
What you need to know before using Sensaval
Do not use Sensaval
Do not take Sensaval
- If you are allergic to nortriptyline or any of the other ingredients of this medicine (listed in section 6).
- If you have recently had a heart attack.
Warnings and cautions
Talk to your doctor or pharmacist before taking Sensaval. This is especially true if you have:
- Epilepsy
- Difficulty urinating
- Enlarged prostate
- Overactive thyroid gland
- Hepatic impairment
- Heart disease e.g. heart failure, arrhythmia.
- Schizophrenia
If you start to feel worse and have thoughts of harming yourself
You who are depressed can 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 adults under the age of 25 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 a hospital if you have thoughts of injuring yourself or committing suicide.
It can be helpful to tell a relative or close friend that you are depressed. 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.
Sensaval can cause dry mouth, which increases the risk of cavities in the teeth. It is therefore important that you make sure you brush your teeth.
If you have been treated for depression with a so-called MAO inhibitor in the last two weeks, you should not use Sensaval.
Contact a doctor if :
- you get an infection with symptoms such as fever with severely deteriorating general condition or fever with local infection symptoms such as sore throat/throat/mouth or urination problems, you should see a doctor as soon as possible so that a blood test can rule out a lack of white blood cells ( agranulocytosis ). It is important that you then have information about your medication.
- you get blurred vision and pain in the eye. This may be a sign of glaucoma ( glaucoma ).
- you have a manic depressive illness and during treatment with Sensaval go into a manic phase. This is characterized by unusual and rapidly changing thoughts, unmotivated joy, and excessive physical activity.
Children and young people
Do not give this medicine to children and adolescents under 18 years of age for these diseases as safety and efficacy have not been established for this age group.
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 exist for Sensaval. Despite this, Sensaval can be prescribed by a doctor to patients under the age of 18, 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 Sensaval
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including medicines obtained without a prescription.
Sensaval can affect the effects of, or be affected by, among other things, the following drugs:
- cimetidine (medicine for stomach ulcers ).
- clonidine (medicine for high blood pressure ).
- an opioid is, e.g. codeine, tramadoldextropropoxyphenephene (painkillers).
- ibuprofen, diclofenac with more so-called NSAIDs (painkillers and anti-inflammatory drugs).
- acetylsalicylic acid with more so-called anticoagulants (blood-thinning drugs).
- carbamazepine, phenobarbital (antiepileptic medicine ) .
- fluoxetine, paroxetine venlafaxine, and sertraline (antidepressants).
- thioridazine, perfenazine, zuclopenthixol, haloperidol, risperidone, chlorpromazine (so-called neuroleptics, anti-schizophrenia drugs, psychosis, and more).
- bupropion (a drug for nicotine addiction).
- fluconazole , terbinafine (antifungal medicine).
- quinidine, propafenone, and flecainide (medicines that affect the heart rhythm).
- promethazine and similar so-called antihistamines (medicines for allergies, itching, motion sickness, anxiety).
- adrenaline (medicines for cardiac arrest, severe allergic reaction, and asthma ).
- dopamine (a drug for shock).
- valproic acid (medicines used to treat epilepsy and bipolar disorder )
If you are going to have an operation and will be anesthetized or have local anesthesia, tell your doctor that you are taking Sensaval. You should also tell your dentist if you will be given a local anesthetic.
Sensaval with food, drink, and alcohol
Alcohol should be avoided during treatment with Sensaval as the negative effects of alcohol may be exacerbated.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
There is a risk that the fetus is affected. Therefore, always consult a doctor before using Sensaval during pregnancy.
The active substance in Sensaval passes into breast milk. A breastfed baby may be affected. Therefore, do not use Sensaval during breastfeeding unless directed to do so by a doctor.
Driving and using machines
Sensaval can in some people impair the ability to react, which should be kept in mind at times when sharper attention is required, e.g. while driving and precision work.
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.
Sensaval contains excipients
Sensaval 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 use Sensaval
Always take this medicine exactly as your doctor has told you. Ask your doctor or pharmacist if you are unsure.
If you have the impression that the effect of Sensaval is too strong or too weak, talk to your doctor or pharmacist.
Adults
The recommended starting dose is 25 mg three times a day, which your doctor may gradually increase to 50 mg three times a day (a total of 150 mg daily).
Elderly patients
The recommended starting dose is 25 mg daily, which your doctor may gradually increase to a total of 100 – 150 mg daily.
Duration of treatment
As with other antidepressants, it may take a few weeks before you begin to feel any improvement.
The duration of treatment is individual and usually at least 6 months. The duration of treatment is determined by your doctor. Keep taking the tablets for as long as your doctor recommends it. Do not stop treatment if you start to feel better. The underlying disease may persist for a long time and if you stop treatment too soon, the symptoms may return. Never change the dosage without first talking to your doctor.
Use for children and adolescents
Sensaval should not be given not to children and adolescents under 18 years. For further information see section 2.
If you use more Sensaval than you should
If you have ingested too much medicine or if e.g. a child has ingested
the medicine accidentally contact a doctor or hospital for risk assessment and advice. Do this even if you / the child does not notice any symptoms. Take the Sensaval pack with you when contacting your doctor or hospital.
If you forget to use Sensaval
If you forget to take a dose, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.
If you stop using Sensaval
Your doctor will decide when and how to stop your treatment to avoid unpleasant symptoms that may occur on abrupt termination (eg headache, malaise, drowsiness, irritability).
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
This medicine can cause side effects like all medicines, although not everybody gets them.
If you get any of the following symptoms, stop taking this medicine and see a doctor immediately:
- Recurrent blurred vision, rainbow vision, and eye pain. Your eyes should be examined immediately before treatment with this medicine can continue. This may be a sign of acute glaucoma. Increased pressure in the eye usually has no signs or symptoms but is a significant risk factor for glaucoma. Uncommon side effects may affect up to 1 in 100 people.
- Severe constipation, swollen stomach, fever, and vomiting (intestinal obstruction). Rare side effects may affect up to 1 in 1,000 people.
- Yellow skin or yellow whites of the eyes (jaundice). Rare side effects may affect up to 1 in 1,000 people.
- Bruising, bleeding, pallor, or persistent sore throat and fever (blood effects such as decreased white blood cell count ( agranulocytosis see Warnings and Precautions)). Rare side effects may affect up to 1 in 1,000 people.
- Thoughts of harming oneself or committing suicide. Adverse reactions with unknown frequency, can not be calculated from the available data.
Other side effects may occur.
Very common side effects (may affect more than 1 user in 10):
- Sweating
- Tremor ( tremor )
- Headache
- Disorder of the eye’s ability to focus
- Dry mouth
- Constipation
- Nausea
- Palpitation
- Fast heartbeat
Common side effects (may affect up to 1 in 10 people):
- Fatigue
- Numbness or tingling sensation in arms and legs
- Influenced coordination
- Enlarged pupils you
- Confusion
- Affected attention
- Decreased sex drive
- Dizziness due to a drop in blood pressure when you get up ( orthostatic hypotension )
- Weight gain
- Abnormal heart rhythm seen as ECG changes
- Men can experience erection problems
- Impact on heart rhythm
Uncommon side effects (may affect up to 1 in 100 people):
- Rash
- Hives
- Swelling of the face and tongue
- Tinnitus (earrings)
- Cramps
- Changes in mood
- Concern
- Sleeping problems
- Nightmares
- Diarrhea
- Vomiting
- High blood pressure
- Difficulty urinating
Rare side effects (may affect up to 1 in 1,000 people):
- Hair loss
- Skin reactions associated with sun exposure
- Decreased appetite
- Confusional state (in elderly patients)
- Hallucinations
- Swelling of the salivary glands
- Enlarged mammary glands
- Fever
- Abnormal heart rhythm or heartbeat
Side effects with unknown frequency (cannot be calculated from the available data):
An increased risk of bone fractures has been seen in patients taking this type of drug.
How to store Sensaval
Keep out of sight and reach of children.
Do not store above 25 ° C.
Do not use this medicine after the expiry date which is stated on the label 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.
Contents of the pack and other information
Content declaration
The active substance is nortriptyline.
Each tablet of Sensaval contains nortriptyline hydrochloride equivalent to 25 mg nortriptyline.
The other ingredients are corn starch, lactose monohydrate, copovidone, 85% glycerol, microcrystalline cellulose, talc, and magnesium stearate.
Film coating: Hypromellos, macrogol.
Dye: Titanium dioxide (E 171).
What the medicine looks like and the contents of the pack
Sensaval tablets have the following appearance:
The tablets are round, slightly biconvex, white, film-coated with a flat top, marked with “NO” on one side, 6 mm in diameter.
Pack sizes:
Marketing Authorization Holder and Manufacturer
H. Lundbeck A / S
Ottiliavej 9
2500 Valby
Denmark
Agent
H. Lundbeck AB
Hyllie Boulevard 34
215 32 Malmö
Tel: 040-699 82 00