Tofranil; Tofranil-PM [DSC]
- Drugs like this one have raised the chance of suicidal thoughts or actions in children and young adults. The risk may be greater in people who have had these thoughts or actions in the past. All people who take this drug need to be watched closely. Call the doctor right away if signs like low mood (depression), nervousness, restlessness, grouchiness, panic attacks, or changes in mood or actions are new or worse. Call the doctor right away if any thoughts or actions of suicide occur.
- This drug is not approved for use in all children. Talk with the doctor to be sure that this drug is right for your child.
- This drug is not approved for use in children. Talk with the doctor.
- It is used to help prevent bedwetting.
- It is used to treat low mood (depression).
- It may be given to your child for other reasons. Talk with the doctor.
- If your child has an allergy to this drug or any part of this drug.
- If your child is allergic to any drugs like this one or any other drugs, foods, or other substances. Tell the doctor about the allergy and what signs your child had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
- If your child has had a recent heart attack.
- If your child has taken certain drugs used for low mood (depression) like isocarboxazid, phenelzine, or tranylcypromine or drugs used for certain other health problems in the last 14 days. Taking this drug within 14 days of those drugs can cause very bad high blood pressure.
- If your child is taking any of these drugs: Linezolid or methylene blue.
If your child is breast-feeding a baby:
- Be sure your child does not breast-feed a baby while taking this drug.
- Tell all of your child’s health care providers that your child is taking this drug. This includes your child’s doctors, nurses, pharmacists, and dentists. This drug may need to be stopped before certain types of surgery as the doctor has told you. If this drug is stopped, the doctor will tell you when to start giving this drug again after your child’s surgery or procedure.
- Alcohol may interact with this drug. Be sure your child does not drink alcohol.
- Talk with your child’s doctor before giving your child other drugs and natural products that may slow your child’s actions.
- Have your child avoid tasks or actions that call for alertness until you see how this drug affects your child. These are things like riding a bike, playing sports, or using items such as scissors, lawnmowers, electric scooters, toy cars, or motorized vehicles.
- To lower the chance of feeling dizzy or passing out, have your child rise slowly if your child has been sitting or lying down. Have your child be careful going up and down stairs.
- Do not stop giving this drug to your child all of a sudden without calling the doctor. Your child may have a greater risk of side effects. If your child needs to stop this drug, you will want to slowly stop it as told by the doctor.
- If your child has high blood sugar (diabetes), you will need to watch his/her blood sugar closely.
- Tell your child’s doctor if your child has signs of high or low blood sugar like breath that smells like fruit, dizziness, fast breathing, fast heartbeat, feeling confused, feeling sleepy, feeling weak, flushing, headache, more thirsty or hungry, passing urine more often, shaking, or sweating.
- It may take several weeks to see the full effects.
- Some people may have a higher chance of eye problems with this drug. The doctor may want your child to have an eye exam to see if your child has a higher chance of these eye problems. Call the doctor right away if your child has eye pain, change in eyesight, or swelling or redness in or around the eye.
- Your child may get sunburned more easily. Avoid lots of sun, sunlamps, and tanning beds. Use sunscreen and dress your child in clothing and eyewear that protects him/her from the sun.
- Have your child be careful in hot weather or while your child is being active. Have your child drink lots of fluids to stop fluid loss.
If your child is pregnant:
- Tell the doctor if your child is pregnant or becomes pregnant. You will need to talk about the benefits and risks of your child using this drug while pregnant.
- If your child is allergic to tartrazine, talk with your child’s doctor. Some products have tartrazine.
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Signs of high or low blood pressure like very bad headache or dizziness, passing out, change in eyesight.
- Feeling confused.
- Hallucinations (seeing or hearing things that are not there).
- Feeling very tired or weak.
- Not able to sleep.
- Bad dreams.
- Fever or chills.
- Sore throat.
- Yellow skin or eyes.
- Any unexplained bruising or bleeding.
- Chest pain or pressure or a fast heartbeat.
- A heartbeat that does not feel normal.
- Shortness of breath, a big weight gain, or swelling in the arms or legs.
- Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
- Ringing in ears.
- A burning, numbness, or tingling feeling that is not normal.
- Trouble controlling body movements, twitching, change in balance, trouble swallowing or speaking.
- Very hard stools (constipation).
- Very bad belly pain.
- Trouble passing urine.
- Mouth irritation or mouth sores.
- Enlarged breasts.
- Nipple discharge.
- Swelling of the testicles.
- Hair loss.
- A very bad and sometimes deadly health problem called serotonin syndrome may happen. The risk may be greater if your child takes this drug with drugs for depression, migraines, or certain other drugs. Call your child’s doctor right away if your child has agitation; change in balance; confusion; hallucinations; fever; a fast or abnormal heartbeat; flushing; muscle twitching or stiffness; seizures; shivering or shaking; sweating a lot; very bad diarrhea, upset stomach, or throwing up; or very bad headache.
If your child is or may be sexually active:
- Not able to get or keep an erection.
- Change in sex interest.
- Hard stools (constipation).
- Dry mouth.
- Upset stomach or throwing up.
- Not hungry.
- Loose stools (diarrhea).
- Change in taste.
- Stomach cramps.
- Feeling sleepy.
- Weight gain or loss.
- Sweating a lot.
- Feeling tired or weak.
- If your child feels sleepy after taking this drug, talk with your child’s doctor. Your child’s doctor may change your child’s dose or when you give this drug.
- To gain the most benefit, do not miss giving your child doses.
- Keep giving this drug to your child as you have been told by your child’s doctor or other health care provider, even if your child feels well.
- Give a missed dose as soon as you think about it.
- If it is close to the time for your child’s next dose, skip the missed dose and go back to your child’s normal time.
- Do not give 2 doses at the same time or extra doses.
- If you take 1 daily dose at bedtime, do not take the missed dose the next morning.
- Store at room temperature.
- Protect from light.
- Store in a dry place. Do not store in a bathroom.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
- If your child’s symptoms or health problems do not get better or if they become worse, call your child’s doctor.
- Do not share your child’s drug with others and do not give anyone else’s drug to your child.
- Keep a list of all your child’s drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your child’s doctor.
- Talk with your child’s doctor before giving your child any new drug, including prescription or OTC, natural products, or vitamins.
- Some drugs may have another patient information leaflet. If you have any questions about this drug, please talk with your child’s doctor, nurse, pharmacist, or other health care provider.
- If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.