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Tifaxin SR 150 mg. 30 tablets

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What Tifaxin SR is and what it is used for

Tifaxin SR contains venlafaxine as active substance.

Tifaxin SR is an antidepressant that belongs to a group of medicines called serotonin and noradrenaline reuptake inhibitors (SNRIs). This group of medicines is used to treat depression and other conditions such as anxiety disorders. People who are depressed and / or anxious are thought to have lower levels of serotonin and noradrenaline in the brain. It is not entirely clear how antidepressants work, but they can help by raising serotonin and noradrenaline levels in the brain.

Tifaxin SR is for treatment for adults with depression. It is also an adult treatment with the following anxiety disorders: generalized anxiety disorder, social anxiety disorder (fear or avoidance of social situations), and panic disorder (panic attacks).
Proper treatment of depression or anxiety disorders is important for you to feel better. If it is not treated, your condition may not go away and may become more serious and more difficult to treat.

2. What you need to know before taking Tifaxin SR

Do not take Tifaxin SR

if you are allergic to venlafaxine or any of the other ingredients of this medicine (listed in section 6).
If you also take or have ever taken within the last 14 days any medicines known as irreversible monoamine oxidase inhibitors (MAOIs) used to treat depression or Parkinson's disease. Taking irreversible MAOIs together with other medicines, including Tifaxix SR, can cause serious or even life-threatening side effects. You should also wait at least 7 days after stopping taking Tifaxin SR before taking any MAOI (see also section "Other medicines and Tifaxin SR" and information in this section on "Serotonin Syndrome").
Warnings and precautions
Please tell your doctor or pharmacist before you start taking Ticapaxin SR

If you use other medicines that are taken concomitantly with Tifaxin SR, you may increase the risk of developing serotonin syndrome (see section "Other medicines and Tifaxin SR")
If you have eye problems such as certain types of glaucoma (increased eye pressure)
If you have a history of high blood pressure
If you have a history of heart problems
If you have an irregular heartbeat
If you have a history of seizures (seizures)
If you have a history of low sodium and blood levels (hyponatraemia)
If you have a tendency to develop bruising or a tendency to bleed easily (a history of blood clotting disorders), or if you are taking other medicines that may increase the risk of bleeding, for example warfarin (used to prevent blood clots)
If you have a history or if someone in your family has had a mania or bipolar disorder (you feel over-excited or euphoric)
If you have a history of aggressive behavior
Tifaxin SR may cause a feeling of anxiety or an inability to sit comfortably in a sitting or standing position. You should tell your doctor if this happens to you.
Tifaxin SR may cause a feeling of anxiety or an inability to stay straight for the first few weeks of treatment.

If you feel this condition, please tell your doctor.

Thoughts of suicide and worsening of your depressive or anxiety disorder
If you are depressed and / or have anxiety disorders, you can sometimes have thoughts of being self-inflicted or suicidal. They can be tightened when you start to take antidepressants for the first time because all these drugs take time before they start to work, usually about two weeks, but sometimes longer.

You are more likely to think like this:

If you had any thoughts of committing suicide or self-harm before.
If you are a youth. Information from clinical trials shows an increased risk of suicidal behavior in young people (under 25 years of age) with psychiatric conditions who have been treated with antidepressants.
If you have any thoughts of harming yourself or suicide, contact your doctor or go to hospital immediately.
It may be helpful to tell a relative or close friend that you are depressed or have an anxiety disorder and ask them to read this leaflet.
You can ask them to tell you if they think your depression or anxiety is getting worse or if they worry about changes in your behavior.

Dry mouth
Dry mouth was reported in 10% of the patients treated with venlafaxine. This can increase the risk of caries. Therefore, you should pay special attention to the hygiene of your teeth.

Diabetes
Blood glucose levels may change due to administration of Tefaxin SR. Therefore, the dose of your antidiabetic medicines should be adjusted.

Children and adolescents
Tifaxin SR should normally not be used for children and adolescents under 18 years of age. Also, you should know that patients under 18 have
Other medicines and Tifaxin SR
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Your doctor should decide whether you can take Tifaxin SR with other medicines.

Do not start or stop taking any medicines, including those bought without a prescription, natural or herbal medicines, before consulting your doctor or pharmacist.

Monoamine oxidase inhibitors that are used to treat depression or Parkinson's disease should not be co-administered with Tifaxin SR. Tell your doctor if you have taken any of these medicines in the last 14 days (MAOI: see section "Before you take TIFAXIN SR")
Serotonin syndrome
Potentially life-threatening or neuroleptic malignant syndrome (NMS) (see section "Possible side effects") may occur with venlafaxine treatment, especially when taken with other medicines. Examples of such drugs include:
Tryptans (used for migraine)
Other medicines to treat depression, such as SNRI, SSRls, tricyclic antidepressants or lithium-containing medicines
Medicines containing linezolid, which is an antibiotic (used to treat infections)
Medicines containing moclobemide, which is an MAOI (used to treat depression)
Medicines containing sibutramine (used to reduce weight)
Medicines containing tramadol, fentanyl, tapentadol, pethidine or pentazocine (for the treatment of severe pain)
Medicines containing dextromethorphan (for cough treatment)
Medicines containing methadone (to treat opioid dependence or severe pain)
Medicines containing methylene blue (used for high levels of methaemoglobin in the blood)
Products containing St John's wort (also called Hypericum perforatum, which is a natural or herbal medicine used to treat mild depression)
Products containing tryptophan (used for problems such as sleep and depression)
Antipsychotics (used to treat a disease associated with symptoms such as hearing, seeing or feeling of non-existent things, wrong thoughts, unusual suspicions, unclear reasoning, and unpredictability).
Signs and symptoms of serotonin syndrome may include a combination of the following: anxiety, hallucinations, loss of coordination, accelerated cardiac activity, increased body temperature, rapid blood pressure changes, overactive reflexes, diarrhea, coma, nausea, vomiting.
In its worst form, serotonin syndrome resembles neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heart beat, sweating, severe muscle stiffness, confusion, increased levels of muscle enzymes (determined by blood tests).

Tell your doctor or seek immediate medical attention at the nearest hospital if you think you are receiving serotonin syndrome.

You should tell your doctor if you are taking medicines that affect your heartbeat.

These are the following drug classes:

antiarrhythmics e.g. quinidine, amiodarone, sotalol, dofetilide (for the treatment of impaired heart rhythm);
some antipsychotics such as thioridazine (see "Serotonin Syndrome" above);
some antibiotics such as erythromycin or moxifloxacin (to treat bacterial infections);
some antihistamines (to treat allergy);
The following medicines may also interact with Trifaxin SR and should be used with caution. It is especially important to tell your doctor or pharmacist if you are taking medicines containing:

Ketoconazole (an antifungal medicine)
Haloperidol or risperidone (for the treatment of psychiatric conditions)
Metoprolol (a beta-blocker for the treatment of high blood pressure and heart problems)
Tifaxin SR with food, beverages and alcohol
Tifaxin SR should be taken with food (see section 3 "How to take Tifaxin SR").

You should avoid drinking alcohol while taking Tifaxin SR.

Pregnancy, breastfeeding and fertility
If you are pregnant or are breast-feeding, think you may be pregnant or plan to become pregnant, ask your doctor or pharmacist for advice before taking this medicine.
You should use Tifaxin SR only after discussing the potential benefits and potential risks to your unborn child with your doctor.

You should make sure that your midwife or doctor knows you are taking Tifaxin SR. When taken during pregnancy, such medicinal products (SIRCs) may increase the risk of serious conditions in newborn babies, called persistent pulmonary hypertension of the newborn (BPHH), which causes the baby to breathe rapidly and lead to bruising. These symptoms usually begin within the first 24 hours after birth. If this happens to your child, you should immediately notify the midwife and / or the doctor.

If you take this medicine during pregnancy, your baby may be born after birth: poor nutrition and difficulty in breathing. If your baby has such symptoms when born and you are worried, contact
Your doctor will advise you on how to stop stopping treatment with Tefaxin SR. If you experience any of these or other symptoms that worry you, talk to your doctor for further advice.

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 everyone gets them.
If you experience any of the following, do not take Tifaxin SR.
Immediately tell your doctor or go to the emergency room of the nearest hospital:

Uncommon (may affect up to 1 in 100 patients)

Swelling of the face, lips, tongue, throat, hands or feet, and / or the appearance of a itchy rash (difficulty swallowing or breathing).
Rare (may affect up to 1 in 1,000 patients)

Chest tightness, wheezing, difficulty swallowing or breathing
Severe skin rash, itching or hives (raised plaques of red or pale skin that often itch)
Signs and symptoms of serotonin syndrome, which may include anxiety, hallucinations, lack of coordination, rapid heartbeat, increased body temperature, rapid changes in blood pressure, overactive reflexes, diarrhea, coma, nausea, vomiting. In its worst form, serotonin syndrome may resemble neuroleptic malignant syndrome (NMS). Signs and symptoms of NMS may include a combination of fever, rapid heartbeat, sweating, severe muscle stiffness, confusion, increased levels of muscle enzymes (found in blood tests)
Signs of infection such as fever, chills, shaking, headaches, sweating, flu-like symptoms. This can lead to blood disruption and an increased risk of infection
Severe rash, which may cause blistering and scaling
Unexplained muscle pain, tenderness or weakness. This may be a sign of rhabdomyolysis.
Other side effects that you should tell your doctor include (the frequency of these reactions is listed in the "Other side effects" section below):

Cough, wheezing, shortness of breath, which may be accompanied by fever
Black (resinous) stools or blood in stools
Pruritus, yellowing of the skin and sclera of the eyes, itching or darkening of the urine, which may be a sign of liver inflammation (hepatitis)
Heart problems such as rapid or irregular heart rhythm, increased blood pressure
Problems with the eyes like blurred vision, enlarged pupils
Nervous problems such as dizziness, needle sensations, movement disorders (muscle spasms or stiffness), seizures or seizures
Psychiatric problems like hyperactivity and feeling of unusual excitement
Withdrawal syndrome (see section "How to take Tifaxin SR", "If you stop taking Tifaxin SR")
Prolonged bleeding time - if you cut or injure, stopping bleeding may take longer.
Do not worry if you notice small white pellets or granules in your stools after taking this medicine. The inside of the capsules of Tifaxin SR is filled with spheres (small balls) containing the active substance (venlafaxine). These spheres are released from the capsule in your stomach. As they move from the stomach to the intestine, venlafaxine is slowly released. The shell of the spheres does not dissolve and separates into your stools. So even if you notice spheres in your stools, your medicine dose is absorbed.

Other undesirable effects observed:
Very common (affects more than 1 user in 10)

Dizziness; headache; drowsiness
Insomnia;
Nausea; dry mouth; constipation
sweating (including night sweats).
Common (affects 1 to 10 patients)

decreased appetite;
Confusion; a sense of isolation (or separation) from oneself; lack of orgasm; decreased libido; agitation; nervousness; pathological dreams;
tremor; feeling anxiety or inability to sit or stand upright; bruising and tingling on the skin; changed taste sensations; increased muscle tone
Vision disorders, including blurred vision; dilated pupils; Inability of the eye to automatically change the focus from distant to close objects
Tinnitus (tinnitus)
Rapid pulse (palpitations)
Increase in blood pressure; redness;
Shortness of breath; yawning
Vomiting; diarrhea
Moderate rash itching
Increased frequency of urination inability to dissect urine difficulty urinating
Irregular menstruation such as increased bleeding or increased but irregular bleeding; unusual ejaculation / orgasm (in men); erectile dysfunction (impotence)
Weakness (asthenia); fatigue; chills
Weight gain; weight reduction;
Increased cholesterol.
Uncommon (affecting up to 1 in 100 patients)

Overactive, skipping thoughts and reduced need for sleep (mania);
Hallucinations; a sense of isolation (or departure) from reality; pathological orgasm; lack of feelings or emotions;
How to store Tifaxin SR

Keep this medicine out of the reach of children.

Do not use this medicine after the expiry date on the box, blister and bottle. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.
Do not dispose of medicines in the sewers or in the household waste container. Ask your pharmacist how to dispose of your unnecessary medicines. These measures will help to protect the environment.

6. Package Contents and Additional Information

What Tefaxin SR contains
The active substance is venlafaxine.

[for 37.5 mg capsules]
One capsule contains 37.5 mg of venlafaxine, such as venlafaxine hydrochloride.

Excipients:
Capsule contents: Sugar spheres (containing sucrose), hydroxypropylcellulose, hypromellose, talc, ethylcellulose, dibutylsebacate, oleic acid, colloidal anhydrous silica.

Capsule shell: Gelatin, sodium lauryl sulphate, colorants: subcoat 4R red (E124), quinoline yellow (E104), titanium dioxide (E171).

[for 75 mg capsules:]
One capsule contains 75 mg of venlafaxine, such as venlafaxine hydrochloride.

Excipients:
Capsule contents: Sugar spheres (containing sucrose), hydroxypropylcellulose, hypromellose, talc, ethylcellulose, dibutylsebacate, oleic acid, colloidal anhydrous silica.

Capsule shell: Gelatin, sodium lauryl sulphate, colorants: subcoat 4R red (E124), quinoline yellow (E104), titanium dioxide (E171).

[for 150 mg capsules:]
One capsule contains 150 mg venlafaxine, such as venlafaxine hydrochloride.

Excipients:
Capsule contents: Sugar spheres (containing sucrose), hydroxypropylcellulose, hypromellose, talc, ethylcellulose, dibutylsebacate, oleic acid, colloidal anhydrous silica.

Capsule shell: Gelatin, sodium lauryl sulphate, coloring agents:
4C red (E124), quinoline yellow (E104), blue V (E131) titanium dioxide (E171) patent.

What Tifaxin SR looks like and contents of the pack
Prolonged-release capsule, hard

TIFFAXIN SR 37.5 mg prolonged-release hard capsule
White to off-white granules in capsule number 3 with orange cap and transparent body of the capsule.
Prolonged-release capsules are released in packs of 14, 20, 28, 30, 50, 56, 98 and 100 prolonged-release capsules packed in PVC / aluminum blisters.

TIFFACE SR 75 mg prolonged-release hard capsule
White to off-white granules in capsule number 1 with a yellow cap and a transparent body of the capsule.
Prolonged-release capsules are presented in packs of 10, 14, 20, 28, 30, 50, 56, 98, 100 and 120 prolonged-release capsules packed in PVC / aluminum blisters.

TIFFACE SR 150 mg prolonged-release hard capsule
White to off-white granules in capsule number "0" with ocher color cover and transparent body of the capsule.
Prolonged-release capsules are presented in packs of 10, 14, 20, 28, 30, 50, 56, 98, 100 and 120 prolonged-release capsules packed in PVC / aluminum blisters.

Packs of 50 and 100 prolonged-release capsules in high density polyethylene bottles with a high density polyethylene screw cap and a silica gel sachet (desiccant) are also available.
Not all pack sizes may be marketed.

 

 

 

 

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