Saroten 10 mg and 25 mg Film-Coated Amitriptyline Tablets
What Saroten Is And What It Is Used For
Saroten belongs to the group of tricyclic antidepressant drugs. Saroten is used in the European Union to treat several conditions, including depression and various depressive states, several disorders associated with chronic (long-term) pain, including migraine or recurring headache prevention, and the treatment of nocturnal enuresis (bedwetting) in children.
Amitriptyline found in Saroten may also be approved for treating other conditions not mentioned in this information. Ask your doctor, pharmacist, or another healthcare professional if you have further questions, and always follow their instructions.
Saroten 25 mg and 10 mg uses for:
- Treatment of depression in adults (actual depression)
- Treatment of neuropathic pain in adults
- Preventive treatment of chronic tension-type headaches in adults
- Preventive treatment of migraine in adults
- Nocturnal bedwetting in children from 6 years. Before treatment, physical (anatomical) causes of nocturnal bedwetting, such as spina bifida and related diseases, were excluded. All other treatments, with and without medication, including muscle relaxants and desmopressin, should also have been without effect. Saroten 25 mg is used only when prescribed by a doctor who has experience treating patients with persistent bedwetting.
What You Need To Know Before Taking Saroten
Do Not Take Saroten:
- If you are allergic to amitriptyline or any of the other ingredients of Saroten (listed in section 6)
- If you have recently had a heart attack (heart attack)
- If you have heart problems, e.g. heart rhythm disorders as seen with ECG, cardiac arrhythmia ( AV block ), or coronary heart disease.
- If you are taking medicines called monoamine oxidase inhibitors ( MAOIs )
- If you have been taking MAOIs for the last 14 days
- If you have taken moclobemide the day before
- If you have severe liver disease.
If you are being treated with Saroten, you must stop Saroten 25 mg uses and wait 14 days before you can start treatment with an MAOI.
Saroten should not be used to treat children younger than 6 years.
Warnings And Cautions About Saroten
Warnings and cautions Saroten 25 mg uses
- Talk to your doctor or pharmacist before taking Saroten.
- Heart rhythm disturbances and low blood pressure may occur if you receive a high dose of amitriptyline. This can also happen with regular doses if you already have pre-existing heart disease.
- Extended QT interval
A heart problem called “prolonged QT interval” (which can be seen on your ECG ) and heart rhythm disturbances (fast or irregular heartbeat) have been reported with Saroten. Tell your doctor if you:
- Has a slow heart rate
- Have or have had problems with your heart not being able to pump blood around the body as well as it should (a condition called heart failure )
- Taking any other medicine that may cause heart problems
- Have problems that cause low levels of potassium or magnesium or high levels of potassium in the blood
- Have an operation booked, as treatment with amitriptyline may need to be stopped before you are given anaesthesia. In emergency surgery, the anaesthetist should be informed about the treatment with amitriptyline.
- Have an overactive thyroid gland or receive treatment with thyroid hormone.
- Suicidal thoughts and worsening depression
You who are depressed can sometimes have thoughts of harming yourself or committing suicide. These thoughts can get worse when you start using antidepressants, as it takes time for drugs of this type to take effect, usually about two weeks but sometimes longer.
These thoughts may be more common:
- If you have previously had thoughts of harming yourself or committing suicide
- If you are a young adult. Data from clinical trials have shown an increased risk of suicidal behaviour in young adults (younger than 25 years) with mental illness who were treated with antidepressant drugs.
Contact a doctor as soon as possible or go to the nearest hospital if you have thoughts of injuring yourself or committing suicide.
It can be helpful to tell a relative or close friend 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 your behaviour is changing.
Manic episodes
Some patients with bipolar disorder may end up in a manic phase. This is characterized by intense and rapidly changing thinking activity, strong elation, and excessive physical activity. If this happens, you must contact your doctor, who will likely change your medication.
Tell your doctor if you have, or have had any medical problems in the past, especially if you have:
- Glaucoma with narrow ventricular angle (visual impairment due to increased pressure in the eye)
- Epilepsy
- Previous seizures
- Difficulty urinating
- Enlarged prostate
- Thyroid disease
- Bipolar disease
- Schizophrenia
- Severe liver disease
- Severe heart disease
- Pyloric stenosis (narrowing of the lower gastrointestinal tract) and paralytic ileus (blocked intestine)
- Diabetes, as your diabetes treatment, may need to be adjusted.
If you use antidepressant drugs such as SSRIs, your doctor may consider changing the dose of one of your medicines (see section 2, Other medicines and Saroten and section 3).
The elderly have an increased risk of certain side effects, such as dizziness when getting up, caused by a drop in blood pressure (see also section 4 Possible side effects ).
Children And Young People
- Depression
- Neuropathic pain
- Chronic tension-type headaches
- Preventive treatment of migraines
Do not give Saroten to children and adolescents under 18 for these diseases, as safety and efficacy have not been established for this age group.
Nocturnal bedwetting
- An ECG should be performed before starting treatment with amitriptyline to rule out long QT syndrome (prolonged QT interval ).
- Saroten should not be taken with anticholinergic medicines (see section 2, Other medicines and Saroten).
- Suicidal and suicidal ideation may also occur in the early stages of treatment with antidepressant drugs for diseases other than depression. The same precautions to be taken when treating patients with depression should therefore be taken when treating patients with bedwetting.
Other drugs and Saroten
Some medicines can affect how other medicines work, which can sometimes cause serious side effects.
Other drugs and Saroten
Some medicines can affect how other medicines work and can sometimes cause serious side effects.
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including:
- MAO inhibitors, e.g. phenelzine, iproniazid, isocarboxazid, nialamide, tranylcypromine (used to treat depression) or selegiline (used to treat Parkinson’s disease ). These should not be taken with Saroten (see section 2 Do not take Saroten)
- Adrenaline, ephedrine, isoprenaline, norepinephrine, phenylephrine, and phenylpropanolamine (these can be found in cough medicines, certain medicines for colds, and certain anaesthetics)
- Antihypertensive drugs such as calcium channel blockers (e.g. diltiazem and verapamil), guanethidine, betanidine, clonidine, reserpine, and methyldopa
- Anticholinergic drugs, such as certain drugs for Parkinson’s disease and gastrointestinal diseases (e.g. atropine, hyoscyamine)
- Thioridazine (used to treat schizophrenia)
- Tramadol (painkiller)
- Medicines for fungal infections (eg fluconazole , terbinafine, ketoconazole and itraconazole)
- Sedatives (e.g. barbiturates )
- Antidepressants (eg SSRIs ( fluoxetine, paroxetine, fluvoxamine), duloxetine, and bupropion)
- Medicines for certain heart diseases (e.g. beta-blockers and antiarrhythmics )
- Cimetidine (used to treat stomach ulcers )
- Methylphenidate (used to treat ADHD )
- Ritonavir (used to treat HIV )
- Rifampicin (used to treat infections )
- Phenytoin and carbamazepine (used to treat epilepsy )
- St. John’s wort ( Hypericum perforatum ) – a herbal remedy used for mild depression and mild anxiety
- Thyroid hormone
- Valproic acid ( valproate )
You should also tell your doctor if you are taking or have recently taken medicines that may affect your heart rhythm, for example:
- Medicines for irregular heartbeats (e.g. quinidine and sotalol)
- Astemizole and terfenadine (used to treat allergies and hay fever)
- Medicines used to treat mental illness (e.g. pimozide and sertindole)
- Cisapride (used to treat certain types of indigestion)
- Halofantrine (used against malaria )
- Methadone (used for pain and detoxification)
- Diuretics (diuretics such as furosemide ).
If you are going to have an operation and get general or local anaesthesia, tell your doctor that you are taking saroten.
In the same way, you should tell your dentist that you are saroten 25 mg uses if you are to receive local anaesthesia.
Saroten With Alcohol
It would help if you did not drink alcohol during treatment while saroten 25 mg uses as the sedative effects (such as drowsiness and lethargy) may worsen.
Pregnancy And Breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before saroten 25 mg uses.
Amitriptyline is not recommended during pregnancy unless your doctor considers it necessary and only after careful analysis of the risks and benefits of treatment. If you have taken the saroten during the latter part of the pregnancy, the newborn baby may experience withdrawal symptoms (withdrawal symptoms) such as
- Anxiety/irritability
- Muscle tension
- Tremors
- Irregular breathing
- Difficulty eating
- Loud crying
- Difficulty urinating
- Constipation
Your doctor will tell you if you should start, continue or stop breastfeeding or stop using the medicine. This is after the doctor has assessed the benefit of breastfeeding for the baby and the benefit of treatment for you.
Driving And Using Machines
Saroten 25 mg uses may cause
- Drowsiness
- Dizziness
especially at the beginning of treatment. Do not drive or use tools if this happens.
You are responsible for assessing whether you can drive a motor vehicle or perform work requiring sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and 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.
Saroten Contains Lactose And Sodium
If your doctor has told you that you have an intolerance to some sugars, contact your doctor before Saroten 25 mg uses.
Saroten contains less than 1 mmol (23 mg) sodium per tablet, i.e. it is essentially ‘sodium-free’.
How To Take Saroten
- Always take Saroten exactly as your doctor has told you. If you are not sure, talk to your doctor.
- Depression
- Adults
- The recommended starting dose of Saroten is 25 mg twice daily.
- Depending on the effect of the medicine, your doctor may gradually increase the dose to 150 mg a day, divided into two doses.
- Elderly (over 65 years) and patients with cardiovascular disease
- The recommended starting dose is 10-25 mg daily.
- Depending on the effect of Saroten, your doctor may gradually increase your dose to a total daily dose of 100 mg, divided into two doses. If you are given a dose in the range of 100-150 mg, your doctor may need to follow up on your treatment more often.
- Use for children and adolescents.
- Saroten should not be given to children or adolescents to treat depression. For more information, see section 2.
- Neuropathic pain
- Chronic tension-type headache
- Preventive treatment of migraine
- Your doctor will adjust the treatment according to your symptoms and your treatment response.
- Adults
- The recommended starting dose of Saroten 10 mg to 25 mg in the evening.
- The recommended daily dose is 25-75 mg.
- Depending on the effect you get from the medicine, your doctor may gradually increase the dose. If you are given a dose of more than 100 mg daily, your doctor may need to monitor your treatment more often. Your doctor will tell you if you should take a dose once daily or divide it into two doses.
- Elderly (over 65 years) and patients with cardiovascular disease
- The recommended initial dose is Saroten 10-25 mg in the evening.
- Depending on the effect you get from the medicine, your doctor may gradually increase the dose. If you are given a dose of more than 75 mg daily, your doctor may need to monitor your treatment more often.
- Use for children and adolescents.
- It should not be given to children and adolescents for the treatment of neuropathic pain, for the treatment of chronic tension-type headaches, or the treatment of migraines. For more information, see section 2.
- Nocturnal bedwetting
- Use for children and adolescents
- The recommended Saroten dose for children:
- For 6 years: see section 2. Do not take Saroten
- Aged 6 to 10 years: 10‑20 mg daily. A suitable dosage form should be used for this age group. From 11 years: 25‑50 mg.
- The dose should be increased gradually according to the doctor’s prescription.
- Take Saroten 1–1½ hours before bedtime.
- Before starting treatment, your doctor will examine your heart with an ECG to see if there are any signs of an unusual heartbeat.
- Your doctor will re-evaluate the treatment after 3 months and, if necessary, take a new ECG.
- Do not stop treatment without first consulting your doctor.
- Patients at particular risk
Patients with liver disease or people known to be “slow metabolizers” of certain drugs usually receive lower doses. Your doctor may take blood samples to check the concentration of amitriptyline in your blood (see section 2).
How And When To Take Saroten
- Saroten can be taken with or without food.
- Swallow the Saroten tablets with a little water. Do not chew them.
- Processing time
- Do not change the medicine dose, and stop taking saroten 10 mg without first consulting your doctor.
- Depression
- As with other antidepressants, it may take a few weeks before you feel any improvement.
- In the treatment of depression, the treatment period is individually adapted and is usually at least 6 months. Your doctor determines the treatment time.
- Please continue to take Saroten for the time your doctor recommends it.
- The underlying disease can persist for a long time. If you stop your treatment too soon, your symptoms may return.
- Neuropathic pain, chronic tension-type headache, and preventive treatment of migraine
- It may take a few weeks before you feel any improvement in your pain.
Talk to your doctor about the duration of treatment and continue to take medicine for the time your doctor recommends.
Nocturnal bedwetting
The doctor will evaluate whether the treatment should continue after 3 months.
If You Take More Saroten Than You Should
If you have ingested too much medicine or if, e.g. If a child has ingested the medicine by mistake, contact a doctor or hospital for risk assessment and advice. Do this even if you do not feel discomfort or show signs of poisoning. Take the Saroten medicine pack with you if you see a doctor or hospital.
Symptoms of Saroten overdose include:
- Large pupils are
- Fast or irregular heartbeat
- Difficulty urinating
- Dry mouth and dry tongue
- Intestinal obstruction (constipation)
- Seizures
- Fever
- Anxiety or physical restlessness
- Confusion
- Hallucinations
- Uncontrolled movements
- Low blood pressure
- Weak pulse
- Pallor
- Breathing difficulties
- Bluish discolouration of the skin
- Decreased heart rate
- Somnolence
- Unconsciousness that can turn into a coma
- Various heart symptoms, such as cardiac arrhythmia ( AV block )
- Heart failure
- Low blood pressure
- Cardiogenic shock (the heart does not pump around enough blood)
- Metabolic acidosis (too low pH in the blood)
- Too low levels of potassium in the blood
Overdose of amitriptyline in children can have serious consequences. Children are particularly sensitive to
- Coma
- Heart symptoms
- Difficulty breathing
- Seizures
- Low levels of sodium in the blood
- Lethargy
- Drowsiness
- Nausea
- Vomiting
- High blood sugar levels
If You Forget To Take Saroten
Take the next dose as usual. Do not take a double dose to make up for a forgotten dose.
If You Stop Taking Saroten
Your doctor will decide when and how to end your treatment to avoid unpleasant symptoms that may occur during a sudden interruption eg.
- Headache
- Malaise
- Insomnia
- Irritability
If you have any further questions about the use of this product, ask your doctor or pharmacist.
Possible Saroten Side Effects
Saroten can cause side effects like all medicines, although not everybody gets them.
If you get any of the following symptoms, consult a doctor immediately:
- Recurrent blurred vision, rainbow vision, and eye pain. Your eyes should be examined immediately before treatment with Saroten can continue. This may be a sign of acute glaucoma. The very rare side Saroten side effects may affect up to 1 in 10,000 people.
- A heart problem is called “prolonged QT interval (which can be seen on your electrocardiogram ( ECG ). The common Saroten side effects may affect up to 1 in 10 people.
- Severe constipation, bloated stomach, fever, and vomiting. These symptoms may be due to parts of the intestinal muscles stopping functioning. The rare Saroten side effects may affect up to 1 in 1,000 people.
- Yellow skin or yellow whites of the eyes (jaundice). Your liver may be affected. The rare Saroten side effect may affect up to 1 in 1,000 people.
- Bruising, bleeding, pallor, or persistent sore throat and fever. These symptoms may be the first signs of an effect on the blood or bone marrow. Effects on the blood can be a reduced number of red blood cells (which carry oxygen in the body), white blood cells (which fight infections ), and platelets (which help the blood clot). The rare side effect may affect up to 1 in 1,000 people.
- Suicidal thoughts or suicidal ideation. The rare side effect may affect up to 1 in 1,000 people.
Adverse reactions listed below have been reported with the following frequencies:
Very common Saroten side effects: may affect more than 1 user in 10
- Drowsiness/drowsiness
- Tremors in the hands or other parts of the body
- Dizziness
- Headache
- Irregular, strong, or rapid heartbeat
- Dizziness due to a drop in blood pressure when you get up ( orthostatic hypotension )
- Dry mouth
- Constipation
- Nausea
- Heavy sweating
- Weight gain
- Slurred or slow speech
- Aggression
- Nasal congestion
Common Saroten side effects: may affect up to 1 in 10 users
- Confusion
- Sexual changes (decreased sexual drive, erection problems )
- Attention deficit disorder
- Taste changes
- Numbness and tingling in the arms and legs
- Coordination difficulties
- Large pupils are
- Cardiac arrhythmia ( AV block )
- Fatigue
- Low sodium content in the blood
- Anxiety
- Physical restlessness
- Various problems with the urinary tract
- Thirst
Uncommon Saroten side effects: may affect up to 1 in 100 people
- Arousal
- Anxiety
- Difficulty sleeping
- Nightmares
- Cramps
- Tinnitus (ringing in the ears)
- High blood pressure
- Diarrhoea
- Vomiting
- Skin rash
- Hives (hives)
- Swelling of the face and tongue
- Difficulty urinating
- Increased production of breast milk or excretion of breast milk (without breastfeeding)
- Elevated pressure in the eye
- Dizziness and fainting
- Aggravated heart failure
- Hepatic impairment (e.g. cholestatic liver disease)
Rare Saroten side effects: may affect up to 1 in 1,000 people
- Decreased appetite
- Delirium, which is a condition with, e.g. decreased consciousness, confusion or loss of reality (in elderly patients), or hallucinations
- Abnormal heart rhythm or irregular heartbeat
- Swollen salivary glands
- Hair loss
- Increased sensitivity to sunlight
- Mammary gland enlargement in men
- Fever
- Weight loss
- Abnormal liver function values
Very rare Saroten side effects: may affect up to 1 in 10,000 people
- Heart muscle disease
- The feeling of inner restlessness and a strong need to be in constant motion
- A condition called peripheral nerve disease, which involves e.g.
- Numbness
- Tingling in the legs and feet
- Sensitivity to touch
- Deterioration of sensation
- Acutely elevated pressure in the eye
- Special forms of abnormal heart rhythm (so-called torsades de pointes )
- Allergic inflammation in the alveoli and the lung tissue
Has been reported that Saroten side effects: occur in an unknown number of users
- Decreased appetite
- Raising or lowering blood sugar
- Paranoia (delusions)
- Motion sickness (involuntary movements or reduced movements)
- Myocarditis due to hypersensitivity reaction
- Inflammation of the liver
- Hot flashes
- Dry eyes
An increased risk of bone fractures has been observed in patients taking this type of medicine.
How To Store Saroten
- Keep Saroten out of sight and reach of children.
- Do not use Saroten after the expiry date stated on the label after EXP. The expiration date is the last day of the specified month.
- Saroten does not require any special storage instructions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Packaging And Other Information
Content Declaration
- The active substance is amitriptyline:
- Each Saroten 10 mg film-coated tablet contains 10 mg of amitriptyline as hydrochloride.
- Each Saroten 25 mg film-coated tablet contains 25 mg of amitriptyline as hydrochloride.
- Other ingredients are:
- Corn starch
- Lactose monohydrate
- Hydrated colloidal silica
- Microcrystalline cellulose
- Crospovidone
- Croscarmellose sodium
- Magnesium stearate
- Film coating:
- Macrogol 400
- Dyes:
- Opadry-OY-S9470 reddish-brown (E 172; E 171)
What The Saroten Looks Like And The Contents Of The Pack
- Round, biconvex, reddish-brown, film-coated tablet.
- Saroten is available in cans of high-density polyethene (HDPE) in the following pack sizes:
- 10 mg: 100 tablets
- 25 mg: 100 tablets
Marketing Authorization Holder And Manufacturer
H. Lundbeck A / S
Ottiliavej 9
2500 Valby
Denmark
Information is provided by
H. Lundbeck AB
Hyllie Boulevard 34
215 32 Malmö
Tel: 040-699 82 00
This medicinal product is authorized under the European Economic Area under the names:
Belgium Redomex
Denmark Saroten
Luxembourg Redomex
Norway Sarotex
Sweden Saroten
Austria Saroten